[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sleep-disturbance\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sleep-disturbance":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,71,0,25,[9,42,80,105,131,158,192,220,247,269,297,323,353,390,410,432,467,493,519,544,569,595,624,653,680],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100652844","tension-type-headache-and-its-association-100652844",false,"NCT07779655","Tension-type Headache and Its Association","Tension-type Headache and Its Association With Smartphone Use,Sleep Quality and Quality of Life","Inclusion Criteria:\n\n* Adults aged 18-60 years\n* Attending the outpatient clinics at Assiut University Hospitals during the study period\n* Able to understand the study questionnaires and provide informed consent\n* No severe psychiatric illness or cognitive impairment interfering with questionnaire completion\n* No serious medical illness that may affect participation\n\nExclusion Criteria:\n\n* History of major neurological diseases (e.g., stroke, epilepsy, brain tumors)\n* History of secondary headache disorders\n* History of migraine or other primary headache disorders according to ICHD-3 criteria\n* Refusal to participate","ALL","18 Years","60 Years",{"count":21,"type":22},199,"ESTIMATED","OBSERVATIONAL","To estimate the prevalence of tension-type headache among adults attending the outpatient clinics at Assiut University Hospitals, and to assess its association with smartphone use, sleep quality, and quality of life.",[26,27,28,29],"Tension-Type Headache","Sleep Disturbance","Smartphone Addiction","Quality of Life","NOT_YET_RECRUITING","2026-08-18",{"date":33,"type":34},"2026-08-21","ACTUAL",{"date":36,"type":22},"2026-08-10",{"date":38,"type":22},"2028-08-10",{"name":40,"class":41},"Assiut University","OTHER",{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":64,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100652310","bao-yuan-tang-extract-and-galactooligosaccharides-for-sleep-regulation-100652310","NCT07774897","Bao Yuan Tang Extract and Galactooligosaccharides for Sleep Regulation","Sleep-Promoting Effects of Bao Yuan Tang Whole-Component Extract Combined With Galactooligosaccharides: A Prospective, Multicenter, Triple-blind, Randomized Controlled Trial","Inclusion Criteria:\n\n* Female registered nurses aged 25-45 years.\n* Participants must meet at least one of the following criteria, self-reported presence of at least one target symptom of the trial, including insomnia, daytime fatigue, or difficulty initiating sleep or Pittsburgh Sleep Quality Index (PSQI) score \\>7.\n* Engagement in shift work for at least one month before enrollment, with either ≥ 4 night shifts or ≥32 hours of night-shift work during the preceding month.\n\nExclusion Criteria:\n\n* Diagnosed with type 1 or type 2 diabetes mellitus and currently receiving pharmacological treatment.\n* Diagnosed with clinically thyroid dysfunction, including hyperthyroidism or hypothyroidism, and currently receiving pharmacological treatment.\n* Diagnosed with Cushing's syndrome, pituitary dysfunction, or other clearly defined endocrine disorders.\n* Diagnosed with polycystic ovary syndrome (PCOS) and currently receiving pharmacological treatment.\n* Use of medications that may affect study outcomes, including oral contraceptives, glucose-lowering agents, hormonal medications, hypnotics, lipid-regulating agents, or thyroid hormone preparations, within the past 3 months.\n* Pregnancy, lactation, or planned pregnancy during the study period.\n* Confirmed severe organic diseases, such as hepatic or renal insufficiency, cardiovascular disease, or malignancy.\n* Known allergy to any component of the investigational product.\n* Use of probiotics, prebiotics, or related traditional Chinese medicine preparations within the past 1 month.\n* Participation in another clinical trial within the past 3 months.\n* Planned engagement in vigorous exercise or a weight-management program during the study period.\n* A previous diagnosis of psychiatric disorders, such as anxiety or depression.\n* Any condition judged by the investigator to involve communication difficulties, poor compliance, or potential interference with adherence to the study protocol.",true,"FEMALE","25 Years","45 Years",{"count":54,"type":22},400,"INTERVENTIONAL",[57],"NA","Certain classical formulas in traditional Chinese medicine and dietary prebiotics have demonstrated beneficial effects on various aspects of suboptimal health status in previous studies. This research aims to evaluate the effects of Bao Yuan Tang full-component extract combined with galactooligosaccharides on improving health-related outcomes in female registered nurse with suboptimal health status, including sleep disturbances, fatigue, endocrine dysregulation, and glucose and lipid metabolic abnormalities.",[27,60,61,62,63],"Fatigue Syndrome, Chronic","Endocrine Disorder","Glucose Metabolism Disorder","Lipid Metabolism Disorders",[65,66,67,68,69],"Bao Yuan Tang full-component extract","Galactooligosaccharides","Sleep quality","Prebiotic","Metabolic health","2026-08-16",{"date":72,"type":34},"2026-08-19",{"date":74,"type":22},"2026-09-30",{"date":76,"type":22},"2027-09-30",{"name":78,"class":41},"Hepatopancreatobiliary Surgery Institute of Gansu Province",6,{"id":81,"slug":82,"hasResults":12,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":49,"sex":17,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":55,"phases":91,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":104},"100650298","radicle-resttm-vgi-a-study-assessing-the-impact-of-health-and-wellness-products-on-sleep-and-related-health-outcomes-100650298","NCT07744997","Radicle RestTM VGI: A Study Assessing the Impact of Health and Wellness Products on Sleep and Related Health Outcomes","Radicle RestTM VGI: A Randomized, Double-Blind, Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Sleep and Related Health Outcomes","3.1 Inclusion\n\nParticipants must meet all the following criteria:\n\n* Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities\n\n  * Assigned sex at birth will determine sex-specific recruitment and PROs (male vs female) employed, when needed\n* Resides in the United States\n* Has the opportunity for at least 30% improvement in their primary health outcome\n* Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study\n\n3.2 Exclusion\n\nIndividuals who report any of the following during screening may be excluded from participation:\n\n* Report being pregnant, trying to become pregnant, or breastfeeding\n* Unable to provide a valid US shipping address and mobile phone number\n* Reports current enrollment in another clinical trial\n* Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)\n* Unable to read and understand English at a 7th grade level\n* Reports a current and\u002For recent (up to 3 months ago) major illness and\u002For surgery that poses a known, significant safety risk.\n* Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known contraindication and\u002For a significant safety risk with any of the study product ingredients.\n\n  * NYHA Class III or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure\n* Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients.\n\n  * Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs, or thyroid products\n* Reports current use of the primary ingredient(s) and\u002For similar product(s) to the active study product(s) that may limit the effects of the study products and\u002For pose a safety risk\n* Lack of reliable daily access to the internet","21 Years","105 Years",{"count":90,"type":22},600,[57],"Radicle RestTM VGI: A randomized, double-blind, placebo- controlled study assessing the impact of health and wellness products on sleep and related health outcomes.",[27],"RECRUITING","2026-08-14",{"date":31,"type":34},{"date":98,"type":22},"2026-08-06",{"date":100,"type":22},"2027-08-06",{"name":102,"class":103},"Radicle Science","INDUSTRY",1,{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":55,"phases":115,"briefSummary":116,"conditions":117,"keywords":118,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":124,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":104},"100616730","effect-of-a-nurse-led-environmental-stressor-reduction-package-on-perceived-stress-and-sleep-quality-in-intensive-care-unit-patients-100616730","NCT07309406","Effect of a Nurse-Led Environmental Stressor Reduction Package on Perceived Stress and Sleep Quality in Intensive Care Unit Patients","Evaluating the Effects of a Nurse-Led Multicomponent Environmental Intervention on Stress Perception and Sleep Quality in ICU Patients: A Quasi-Experimental Study","ICU-SLEEP","Inclusion Criteria:\n\n* Adults aged 18 years and older\n* Admitted to the intensive care unit (ICU)\n* Awake and able to communicate\n* Not receiving sedation or invasive mechanical ventilation\n* Expected to remain in the ICU for at least 2 consecutive nights\n* Willing to participate and provide written informed consent\n\nExclusion Criteria:\n\n* Younger than 18 years of age\n* Diagnosed with delirium or severe cognitive impairment\n* Presence of a psychiatric condition that may substantially affect sleep or perceived environmental stress\n* Receiving continuous sedative or opioid infusion\n* Discharged from the ICU or deceased before completion of the required study assessments",{"count":114,"type":22},68,[57],"This study aims to evaluate the effect of a nurse-led Environmental Stressor Reduction Package on perceived environmental stress and sleep quality among adult patients in the intensive care unit (ICU).\n\nThe Environmental Stressor Reduction Package is a structured, multicomponent nursing intervention designed to reduce potentially disturbing environmental stimuli during nighttime care. The package focuses on reducing unnecessary noise, optimizing nighttime lighting, supporting thermal comfort, limiting nighttime visitor activity, and organizing nursing care to minimize avoidable sleep interruptions while maintaining patient safety and essential clinical care.\n\nParticipants in the intervention group will receive the Environmental Stressor Reduction Package during their ICU stay, while participants in the control group will receive standard ICU care. The study will assess whether the nurse-led intervention reduces perceived environmental stress and improves self-reported sleep quality compared with standard care.\n\nPerceived environmental stress will be assessed using the Intensive Care Unit Environmental Stressor Scale (ICUESS), and sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire (RCSQ).",[27],[119,120,121,122,123],"Critical Care Nursing","Environmental Stressors","Intensive Care Unit","Sleep Quality","Quiet Night Protocol",{"date":31,"type":34},{"date":126,"type":22},"2026-09-01",{"date":128,"type":22},"2027-01-31",{"name":130,"class":41},"Fenerbahce University",{"id":132,"slug":133,"hasResults":12,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":12,"sex":17,"minAge":138,"maxAge":139,"enrollmentInfo":140,"targetDuration":4,"studyType":55,"phases":142,"briefSummary":143,"conditions":144,"keywords":146,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":104},"100545755","the-power-down-pilot-study-a-novel-bedtime-manipulation-protocol-100545755","NCT06386029","The Power Down Pilot Study: A Novel Bedtime Manipulation Protocol","Powering Down: A Pilot Study of a Bedtime Manipulation to Support Sleep for Autistic Children","Inclusion Criteria:\n\n1. Child between the ages of 6 and 10 years old (at least 40%, no more than 60% female)\n2. Parent-reported autism diagnosis for child\n3. Parent-reported extended and problematic settling down delay\n4. Parent-reported sensory over-responsivity (a \"yes\" to at least 8 items in the sensory screening section of the checklist)\n5. Parent willing to participate in nightly routine during the 2 week study\n6. Located within the Pittsburgh area\n\nExclusion Criteria:\n\n1. Participants will be excluded if they do not understand English or are unable to travel to University of Pittsburgh Medical Center Western Psychiatric Hospital.\n2. Children who have trauma or other histories for whom physical touch is triggering (per caregiver report) will be excluded.\n3. If a child spends bedtime at a different caregiver's home for \\>50% of the nights and that caregiver is not willing to participate in this study, the child will be excluded from this study.","6 Years","10 Years",{"count":141,"type":22},10,[57],"The goal of this pilot intervention study is to examine the feasibility and acceptability of a novel bedtime manipulation protocol called \"The Power Down\" for autistic youth, ages 6-10. The main questions it aims to answer are:\n\n1. Is the Power Down feasible for caregivers to do each night?\n2. Do the families find the Power Down an acceptable intervention to address their child's difficulties settling down to fall asleep?",[145,27],"Autism",[147,148,149],"Sleep disturbances","Emotion Dysregulation","Sensory Processing","2026-08-12",{"date":95,"type":34},{"date":153,"type":34},"2025-07-05",{"date":155,"type":22},"2026-12",{"name":157,"class":41},"University of Pittsburgh",{"id":159,"slug":160,"hasResults":12,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":12,"sex":17,"minAge":165,"maxAge":166,"enrollmentInfo":167,"targetDuration":4,"studyType":55,"phases":169,"briefSummary":170,"conditions":171,"keywords":178,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":185,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":104},"100531005","weighted-blankets-for-sleep-disturbance-among-children-with-adhd-100531005","NCT06194162","Weighted Blankets for Sleep Disturbance Among Children With ADHD","Impact of Weighted Blankets on Sleep Disturbance Among Children With Attention Deficit Hyperactivity Disorders: A Pragmatic Randomised Trial","Inclusion Criteria:\n\n1. Signed informed consent.\n2. Age 5-12 years (both included) at randomization.\n3. Primary diagnosis of ADHD according to ICD-10 code F90.0, F90.1, F90.9 or F98.8.\n4. Comorbidities are allowed.\n5. Participated in a usual care sleep hygiene program managed by clinicians without effect within 6 months prior to enrollment.\n6. If on ADHD medication or\u002Fand melatonin\u002Fsleep medication the dose must be stable, at least two weeks prior to enrollment.\n7. The child and caregiver have adequate mastery of the Danish language.\n\nExclusion Criteria:\n\n1. Have used any type of medical device class 1 weighted blanket before.\n2. Any diagnosed diseases that markedly compromises the participant's ability to adhere to the intervention (like mental retardation, severe underweight, chronic respiratory or circulatory conditions, surgical implants, osteoporosis).\n3. Another member of the household enrolled in the trial.","5 Years","12 Years",{"count":168,"type":22},340,[57],"Many children with ADHD suffer from sleep disorders and dysfunction, which may affect development and well-being. According to the clinicians, some children find relief from restlessness and difficulty sleeping by using weighted blankets which have been proposed to reduce restlessness and stress via sensory integration and to calm the child by stimulating the sense of touch, muscles and joints. However, evidence for an effect on sleep is scarce, and only one RCT has investigated the effect of weighted blankets among children with ADHD. Using a RCT design, the aim is to investigate the effect on sleep disorders and dysfunction in children with ADHD aged 5-12 years by (1) using a weighted blanket during night and daytime in addition to usual treatment, compared to (2) usual treatment and a non-weighted sham blanket, with the primary outcome being differences in total sleep time. Results will support health- and social professionals who are involved in the treatment of children with ADHD.",[172,173,174,27,175,176,177],"Attention-deficit Hyperactivity","Attention Deficit Hyperactivity Disorder","Neurodevelopmental Disorders","Attention Deficit Disorder","Hyperkinetic Conduct Disorder","Attention-Deficit Hyperactivity Disorder, Unspecified Type",[179,180,181,182,27,183,184],"ADHD","weighted blanket","Children","Randomised controlled trial","ADD","Functional impairment",{"date":95,"type":34},{"date":187,"type":34},"2024-01-01",{"date":189,"type":22},"2028-12-31",{"name":191,"class":41},"University Hospital Bispebjerg and Frederiksberg",{"id":193,"slug":194,"hasResults":12,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":55,"phases":201,"briefSummary":202,"conditions":203,"keywords":205,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":104},"100578587","dream2heal-an-adaptive-stepped-care-intervention-for-chinese-cancer-survivors-with-mild-to-moderate-insomnia-100578587","NCT06813235","Dream2Heal: An Adaptive Stepped-care Intervention for Chinese Cancer Survivors With Mild-to-moderate Insomnia","Dream2Heal: A Pilot Sequential Multiple Assignment Randomized Trial (SMART) of an Adaptive Stepped-care Intervention for Chinese Cancer Survivors With Mild-to-moderate Insomnia","Inclusion Criteria:\n\n* Cantonese- or Mandarin-speaking Chinese patients diagnosed with curable breast, colorectal, or gynaecological cancer\n* Completed treatment (except endocrine therapy) within two years\n* Presenting with Pittsburgh Sleep Quality Index (PSQI) score of 6 to 11 indicating mild-to-moderate sleep disturbance\n\nExclusion Criteria:\n\n* Diagnosis of metastatic cancer\n* Current diagnosis of psychiatric disorder\n* Current diagnosis of another sleep disorder,\n* Have received psychological treatment specifically for sleep disturbance",{"count":200,"type":22},72,[57],"The primary objective of this feasibility study is to assess the feasibility and acceptability, and potential clinical significance of an adaptive stepped-care intervention for improving sleep quality among Chinese cancer patients with mild-to-moderate sleep disturbance, using a sequential multiple assessment randomized controlled trial (SMART) design.",[204,27],"Neoplasm",[206,207,208,209,210],"Sequential multiple assessment randomized controlled trial","sleep disturbance","cancer survivors","insomnia","Survivorship intervention","2026-08-11",{"date":213,"type":34},"2026-08-13",{"date":215,"type":34},"2025-02-01",{"date":217,"type":22},"2027-02-02",{"name":219,"class":41},"The University of Hong Kong",{"id":221,"slug":222,"hasResults":12,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":226,"eligibilityCriteria":227,"healthyVolunteers":49,"sex":17,"minAge":18,"maxAge":228,"enrollmentInfo":229,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":231,"conditions":232,"keywords":234,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":104},"100524097","medications-for-opioid-use-disorder-photosensitive-retinal-ganglion-cell-function-sleep-and-circadian-rhythms-implications-for-treatment-100524097","NCT06104280","Medications for Opioid Use Disorder Photosensitive Retinal Ganglion Cell Function, Sleep, and Circadian Rhythms: Implications for Treatment","Medications for Opioid Use Disorder Differentially Modulate Intrinsically Photosensitive Retinal Ganglion Cell Function, Sleep, and Circadian Rhythms: Implications for Treatment (MOUD)","MOUD","Inclusion Criteria:\n\n1. Adults (18+)\n2. prescribed one of three medications for opioid use disorder (methadone, XR-NTX, buprenorphine) or healthy control\n3. stable on MOUD (no dose change) for the past month\n4. positive on urine drug screen (UDS) for buprenorphine or methadone if prescribed those medications\n\nExclusion Criteria:\n\n1. eye disease reported by history or noted on exam including disease of the anterior and posterior segment of the eye, cataracts, retinopathy, glaucoma, cataracts, amblyopia, scotoma, color or night blindness, corneal pathologies, macular degeneration, or retinitis pigmentosa;\n2. acutely suicidal, manic, intoxicated, or otherwise not stable enough to provide informed consent\n3. self-reported use of illicit opioids, stimulants (prescribed or illicit), or benzodiazepines\u002Fsedative\u002Fhypnotics in the past month\n4. alcohol or cannabis use disorder measured as severe on The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Checklist\n5. positive on UDS for illicit opioids (e.g., morphine, oxycodone, fentanyl),stimulants, benzodiazepines\u002Fsedative\u002Fhypnotics\n6. shift workers who work outside normal 7 a.m. to 6 p.m. hours, according to the National Institute of Occupational Safety and Health (NIOSH)\n7. persons diagnosed with narcolepsy","80 Years",{"count":230,"type":22},200,"Opioid use disorder (OUD) is a treatable medical illness with three medications FDA approved for treatment. However, persons with OUD report significant sleep disturbance, even when treated with medications for opioid use disorder, leading to high rates of relapse. In this project, we will investigate a special set of photosensitive neurons in the retina as an underlying mechanism for circadian rhythm and sleep disturbance from opioid use and medications for OUD that could lead to novel intervention and improve treatment outcomes.",[233,27],"Opioid Use Disorder",[235,236,237,238],"opioid use disorder","sleep","circadian rhythms","sleep disruption","2026-08-07",{"date":211,"type":34},{"date":242,"type":34},"2025-01-06",{"date":244,"type":22},"2029-01-01",{"name":246,"class":41},"University of Alabama at Birmingham",{"id":248,"slug":249,"hasResults":12,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":49,"sex":17,"minAge":87,"maxAge":228,"enrollmentInfo":254,"targetDuration":4,"studyType":55,"phases":256,"briefSummary":257,"conditions":258,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":104},"100650758","gut-feelings-using-citizen-science-for-large-scale-prebiotic-clinical-trials-for-mental-health-in-adults-100650758","NCT07752823","GUT-FEELINGS: Using Citizen Science for Large-Scale Prebiotic Clinical Trials for Mental Health in Adults","GUT-FEELINGS: Using Citizen Science for Large-Scale Prebiotic Clinical Trials for Mental Health in Adults, Wave 1","Criteria: 3.1 Inclusion\n\nParticipants must meet all of the following criteria:\n\n* Adults aged 21-80 years (inclusive) at the time of electronic informed consent, of any ethnicity, race, or gender identity\n* Assigned sex at birth determines sex-specific PRO branching (e.g., menstrual interference) where applicable\n* Reside in the contiguous 48 states in the United States and is able to provide a valid US shipping address and and 10-digit mobile phone number\n* Per state regulations, individuals residing in New York, New Jersey, and Rhode Island will be excluded\n* Capable of providing voluntary, electronic informed consent and willing to comply with study procedures, including remote biospecimen collection\n* PROMIS Anxiety 8A T-score between 55.0 and 69.9 (inclusive) at screening, corresponding to mild-to-moderate anxiety symptoms.\n* On a stable medication regimen for ≥30 days prior to screening and willing to maintain that regimen for the duration of the trial, unless changes are deemed medically necessary by the participant's healthcare provider. Stable, prescribed psychotropic medications (including SSRIs, SNRIs, and other antidepressants or anxiolytics) are not exclusionary.\n* Willing to take a study product and not know the intervention arm assignment (active or placebo) or the product identity.\n* Reliable daily access to the internet via mobile device or computer\n\n3.2 Exclusion\n\nIndividuals who report any of the following during screening may be excluded from participation:\n\n* Currently pregnant, planning to become pregnant during the trial, or breastfeeding\n* Unable to read and understand English at a 7th-grade reading level\n* Currently enrolled in another interventional clinical trial or planning to enroll in one during the trial timeline\n* Heavy alcohol consumption (defined for female sex assigned at birth \\>\u002F= 2 alcoholic beverages\u002Fday, male sex assigned at birth \\>\u002F=3\u002Fday) or use of recreational or illicit drugs other than cannabis\n* History of bariatric or weight-loss surgery (e.g., Roux-en-Y gastric bypass, sleeve gastrectomy, adjustable gastric banding, or biliopancreatic diversion).\n* Reports a current diagnosis of inflammatory bowel disease (ulcerative colitis or Crohn's disease).\n* Current or recent (within 3 months) major illness, surgery, or hospitalization posing a known significant safety risk\n* Diagnosis of cardiac dysfunction, severe liver disease, or severe kidney disease that presents a known contraindication to study product ingredients or substantial safety risk:\n* NYHA Class III or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure\n* Significant immunocompromise, including diagnosed primary or acquired immunodeficiency, current chemotherapy, current immunotherapy, current use of immunosuppressive medications, or daily corticosteroid dose \\>5 mg prednisone-equivalent\n* Antibiotic use (oral, IV) currently or within 30 days prior to screening\n* Plans to start a new structured dietary regimen (including new probiotic or prebiotic supplementation outside the study product) during the trial period\n* Use of medications with a well-established interaction posing a substantial safety risk with study product ingredients\n* Active suicidality as determined by a response of 3 in item 9 of the PHQ-9 score at screening\n* Known hypersensitivity to any component of the study products\n* Wave-specific exclusion criteria per Subprotocol A (Wave 1) or Subprotocol B (Wave 2)\n\nNote on medication exclusions: routine prescription medications (including antihypertensives, anticoagulants at standard outpatient doses, antiseizure medications, and medications carrying a grapefruit-consumption warning) are not categorically excluded. Specific medications posing a documented safety risk in combination with the food ingredients (products) are addressed by the study screening Q-bank.\n\n* Participants residing in the states of New York, New Jersey, or Rhode Island are not eligible to participate in the study. This restriction is due to state regulatory requirements governing direct-to-consumer at-home laboratory specimen collection and processing that cannot be accommodated within the fully decentralized design of the study. No alternative collection pathway is available under the current protocol.\n* To ensure compliance, state-of-residence logic is built into the enrollment platform. Participants who indicate a residential address in New York, New Jersey, or Rhode Island will not be eligible. This automated screening ensures that ineligible participants are not inadvertently enrolled in the study.",{"count":255,"type":22},1000,[57],"The goal of this study is to evaluate the effects of different products in participants experiencing feelings of anxiety. The main question it aims to answer is:\n\n\\- Do these products affect feelings of anxiety and related wellness outcomes compared with a placebo?\n\nResearchers will compare participants taking active products to those taking a placebo to see whether the active products influence feelings of anxiety and related outcomes, and to monitor safety.\n\nParticipants will:\n\n* Be randomly assigned to receive either an active product or a placebo (an inactive look-alike).\n* Take their assigned product or placebo without knowing which group they are in until the study is completed.\n* Complete evaluations and tasks to track safety, feelings of anxiety, and related health outcomes.",[27,259,260],"Stress","Feeling Anxious","2026-08-04",{"date":239,"type":34},{"date":264,"type":22},"2026-08-20",{"date":266,"type":22},"2027-08",{"name":268,"class":103},"Holobiome, Inc.",{"id":270,"slug":271,"hasResults":12,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":275,"eligibilityCriteria":276,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":277,"enrollmentInfo":278,"targetDuration":4,"studyType":55,"phases":280,"briefSummary":281,"conditions":282,"keywords":284,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":295,"locationsCount":104},"100515092","sleep-interventions-and-neurocognitive-outcomes-100515092","NCT05987007","Sleep Interventions and Neurocognitive Outcomes","Sleep Interventions and Neurocognitive Outcomes in Amnestic Mild Cognitive Impairment","SINA","Inclusion Criteria:\n\n1. English speaking participants, ages 60-85 years\n2. Telephone MMSE (T-MMSE) score of 22 or greater at screening assessment; T-MMSE \\\u003C18 during post-treatment visit or 6-month follow-up will be discontinued from participation of the study.\n3. Individuals with aMCI, as determined by the Wechsler Memory Scale-Revised Logical Memory Delayed Recall (LM) and Quick Dementia Rating Scale (QDRS)\n4. Presence of subject memory complains not exclusionary. Presence of subjective memory complaints without objective signs of impairment (T-MMSE, QDRS, LM) would not be considered as the presence of late MCI or dementia, therefore are not exclusionary.\n5. Participants with regular and consistent use of sleep medications (sedatives\u002Fhypnotic use of \\>3 times per week) will be excluded. Participants who take sleep medications 3 or less times per week will be asked to discontinue medications prior to the study baseline visit. All discontinuation\u002Ftapering procedures will require PI's direct consultation with participants' prescribing or primary care physicians, which will be documented to ensure participants' safety.\n6. Presence of sleep disturbance, as determined by score of 8 or greater on the Insomnia Severity Index administered at baseline (without sleep medications).\n7. Participants must have capacity to provide informed consent.\n8. Have access to stable internet connection.\n9. A family member or other individual who is in contact with the subject and consents to serve as informant during the study; this can be a telephone informant in the case of subjects who do not have a live-in informant\n\nExclusion Criteria:\n\n1. Diagnosis of stroke or excessive risk of CVD\n2. Neurologic disease including movement disorders, MS, epilepsy, and TBI (with greater than 15 min loc)\n3. Untreated diabetes\n4. Active treatment of cancer\n5. Telephone MMSE score below 22 (Newkirk et al., 2004) and Logical Memory above 11 for subjects with 16 or more years of education, 9 for subjects with 8-15 years of education, and 6 for subjects with 0-7 years of education\n6. Presence of sleep disorders other than insomnia (moderate-severe sleep apnea, REM-behavior disorder, restless legs syndrome, circadian rhythm disorder). Mild sleep apnea will not be exclusionary.\n7. Current DSM-5 Axis I psychiatric diagnosis of schizophrenia, schizoaffective disorder, substance\u002Falcohol use disorder, or bipolar disorder\n8. Use of antidepressants with known large anticholinergic properties will be excluded. These include: amitriptyline, amoxapine, clomipramine, desipramine, doxepine, imipramine, isocarboxazide, lithium, maprotiline, mirtazapine, nortriptyline, tranylcypromine trimipramine, and phenelzine. Other medications are allowed during the study and are not exclusionary.\n9. Participants taking medications with benzodiazepines properties will be excluded. These include: diazepam, quazepam, estazolam, alprazolam, clorazepate, clorazepate, oxazepam, alprazolam, chlordiazepoxide, lorazepam, flurazepam, triazolam, temazepam, and midazolam.\n10. Participants with moderate to severe depression (Geriatric Depression Scale\\>8) will be excluded from the study and will be encouraged to seek treatment for their symptoms. Participants with moderate depression (GDS 5-8) will be encouraged to return for screening after receiving treatment and seeing improvement in their symptoms.\n11. Participants who are unable to provide an informant.","85 Years",{"count":279,"type":22},50,[57],"This protocol focuses on the effect of sleep interventions on improving sleep and building cognitive\u002Fbrain resilience in older adults with amnestic mild cognitive impairment and sleep disturbance. Two sleep interventions, cognitive behavioral therapy for insomnia (CBTI) and acoustic slow-wave activity enhancement (SWAE), will be utilized in a pilot randomized clinical trial in which participants are randomized to different treatment groups (CBTI or SWAE). Participants will be assessed over a 6-month period in order to examine the impact of sleep treatments on neuropsychological outcomes and cognitively mediated everyday functioning.",[27,283],"Amnestic Mild Cognitive Impairment",[285,286,287,283,288],"Alzheimer's Disease","Slow-Wave Activity","Older Adults","Cognitive Behavioral Therapy for Insomnia","2026-07-30",{"date":291,"type":34},"2026-08-03",{"date":293,"type":22},"2026-08-01",{"date":189,"type":22},{"name":296,"class":41},"New York State Psychiatric Institute",{"id":298,"slug":299,"hasResults":12,"nctId":300,"briefTitle":301,"officialTitle":301,"acronym":4,"eligibilityCriteria":302,"healthyVolunteers":49,"sex":17,"minAge":303,"maxAge":4,"enrollmentInfo":304,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":306,"conditions":307,"keywords":310,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":320,"locationsCount":322},"100624826","integrating-systematic-data-of-medicine-to-explore-the-solution-for-healthy-aging-isdha-phase-4-100624826","NCT07414680","Integrating Systematic Data of Medicine to Explore the Solution for Healthy Aging (ISDHA) Phase 4","Inclusion Criteria:\n\n* Willing to sign a written participant consent form.\n* Males or females aged 40 or above who have participated in the \"Integrated Systematic Geriatric Medical Information to Explore Solutions for Healthy Aging (Pilot Project),\" the \"Integrated Systematic Geriatric Medical Information to Explore Solutions for Healthy Aging\" master planner, or the \"Integrated Systematic Medical Information to Explore Solutions for Healthy Aging\" project (not subject to exclusion criteria).\n* Males or females aged 40-59 who have participated in health checkups for employees of Chang Gung Memorial Hospital, Formosa Plastics Group, or Chang Gung University.\n* Those with a medical record of more than one year at Chang Gung Memorial Hospital.\n* Those who have resided in Taiwan for more than 180 days in the past year.\n\nExclusion Criteria:\n\n* Individuals with severe organ abnormalities, such as: heart failure (NYHA Fc ≥ III), chronic obstructive pulmonary disease (hospitalization\u002Femergency room visit or medication adjustment within the past month due to disease worsening), decompensated cirrhosis, hemodialysis, or currently undergoing cancer treatment.\n* Individuals with a history of severe autoimmune diseases.\n* Individuals with a preliminary cognitive and mental assessment score of \\\u003C26 on the Mini-Mental State Examination (MMSE) or ≥5 on the Generalized Depression Scale (GDS).\n* Individuals (who agree to undergo brain MRI) who are deemed unsuitable for MRI after evaluation (e.g., those with pacemakers, cochlear implants, or spatial phobia).\n* Individuals who have taken antibiotics within the past month.\n* Individuals whose hearing, vision, or cognitive impairments affect communication.\n* Individuals unable to stand or walk (with a walking aid) or with unsteady gait when walking.\n* Those who have undergone follow-up outpatient assessments that may affect cognitive function, including but not limited to stroke, Parkinson's syndrome, Parkinson's dementia, epilepsy, brain tumor, or a history of mental illness such as schizophrenia, severe depression, bipolar disorder, alcohol or drug abuse, or a history of loss of consciousness due to severe head trauma.\n* Those currently diagnosed with depression and undergoing treatment.\n* Those with a past medical history confirming dementia, depression, etc..\n* Those deemed unsuitable by a physician.","40 Years",{"count":305,"type":22},250,"This project aims to build up the comprehensive health database of geriatric medicine for middle-aged and elderly people in Taiwan.",[27,308,309],"Cognitive Change","Aging",[311,312,313,314],"dementia","depression","brain structure","system biology","2026-07-29",{"date":289,"type":34},{"date":318,"type":22},"2026-09-15",{"date":189,"type":22},{"name":321,"class":41},"Chang Gung Memorial Hospital",2,{"id":324,"slug":325,"hasResults":12,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":4,"eligibilityCriteria":329,"healthyVolunteers":49,"sex":17,"minAge":18,"maxAge":330,"enrollmentInfo":331,"targetDuration":4,"studyType":55,"phases":333,"briefSummary":334,"conditions":335,"keywords":337,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":349,"leadSponsor":351,"locationsCount":104},"100649756","effects-of-exercise-intervention-on-sleep-quality-and-emotional-problems-in-college-students-with-depressive-symptoms-100649756","NCT07738809","Effects of Exercise Intervention on Sleep Quality and Emotional Problems in College Students With Depressive Symptoms","Effects of Exercise Intervention on Sleep Quality, Emotional Problems, and Neuroelectrophysiological Mechanisms in College Students With Depressive Symptoms","Inclusion Criteria:\n\n* • Aged 18-23 years.\n\n  * Right-handed.\n  * Non-physical education major.\n  * No history of psychiatric disorders and no current or previous use of psychotropic medications, hypnotics, or other medications affecting the central nervous system.\n  * No history of traumatic brain injury or chronic physical diseases.\n  * No contraindications to physical exercise.\n  * Participants with a Beck Depression Inventory-II (BDI-II) score \\>13 will be classified as having depressive symptoms, whereas participants with a BDI-II score ≤13 will be classified as having no depressive symptoms.\n\nExclusion Criteria:\n\n* Vigorous physical exercise, alcohol consumption, caffeine intake, or other stimulating behaviors within 24 hours before testing.\n\n  * Withdrawal from the study before completion of EEG recording or behavioral task assessments.\n  * Participants will be excluded from the final analysis if they fail to complete the required questionnaires or if the collected data do not meet predefined quality control criteria.","23 Years",{"count":332,"type":22},80,[57],"This exploratory randomized controlled trial aims to investigate the immediate and long-term effects of exercise on sleep quality, emotional problems, executive function, and neurophysiological characteristics in college students with depressive symptoms. The study consists of two sequential phases: an acute exercise experiment followed by an 8-week exercise intervention. Participants will be randomly assigned to either an exercise intervention group or a control group. Psychological questionnaires, behavioral tasks, resting-state electroencephalography (EEG), brain functional connectivity, and event-related potentials (ERP) will be assessed to evaluate behavioral and neurophysiological changes before and after exercise. The study will further examine whether the immediate response to acute exercise predicts the effectiveness of the long-term intervention.",[336,27],"Depressive Symptoms",[338,339,336,122,340,341,342,343,344],"Exercise","College Students","Electroencephalography","Brain Functional Connectivity","Event-Related Potentials","Executive Function","Randomized Controlled Trial","2026-07-28",{"date":347,"type":34},"2026-07-31",{"date":293,"type":22},{"date":350,"type":22},"2026-12-30",{"name":352,"class":41},"Capital University of Physical Education and Sports, China",{"id":354,"slug":355,"hasResults":12,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":359,"eligibilityCriteria":360,"healthyVolunteers":12,"sex":361,"minAge":18,"maxAge":4,"enrollmentInfo":362,"targetDuration":4,"studyType":55,"phases":364,"briefSummary":365,"conditions":366,"keywords":371,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":384,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":104},"100649459","emindexcare-for-prostate-cancer-patients-undergoing-active-treatment-100649459","NCT07735273","eMindExCare for Prostate Cancer Patients Undergoing Active Treatment","Effects of Integrated Mindfulness and Exercise eHealth Intervention (eMindExCare) on Sleep, Fatigue, and Physical Activity Among Prostate Cancer Patients Undergoing Active Treatment: A Feasibility Trial","eMindExCare","Inclusion Criteria:\n\n1. Diagnosed with prostate cancer, stage I, II, or III.\n2. Aged older than 18 years.\n3. Undergoing active treatment, including chemotherapy, radiotherapy, or hormone therapy, at Prince of Wales Hospital.\n4. Able to communicate and read Chinese.\n5. Has access to the Internet and a computer or tablet.\n6. Demonstrates clinically impaired sleep quality or insufficient physical activity as measured by ActiGraph. Clinically impaired sleep quality may include study-defined sleep disturbance criteria such as total sleep time less than 6.5 hours, sleep onset latency greater than 30 minutes, awakenings lasting greater than 5 minutes, or wake after sleep onset greater than 30 minutes.\n\nExclusion Criteria:\n\n1. Diagnosed with more than one primary cancer.\n2. Has metastatic disease.\n3. Has participated in a mindfulness programme.\n4. Is sufficiently physically active at the time of recruitment.\n5. Has a mental condition, World Health Organization\u002FEastern Cooperative Oncology Group performance status greater than 2, a physical disability that prevents participation in the intervention, or any other health problem that rules out regular physical activity as determined by the treating physician.","MALE",{"count":363,"type":22},60,[57],"This feasibility randomized controlled trial will assess the acceptability, feasibility, and preliminary effects of an integrated mindfulness and exercise eHealth intervention, eMindExCare, among prostate cancer patients undergoing active treatment in Hong Kong. Participants will be randomized in a 1:1 ratio to either an 8-week eMindExCare intervention or an enhanced health education attention-control programme. eMindExCare integrates culturally adapted Cantonese mindfulness practices with home-based aerobic and resistance exercise delivered through Zoom, supported by home practice, exercise logs, and weekly reminders. The enhanced health education control programme will match the intervention group in contact time and engagement but will not include progressive aerobic training, resistance-band prescription, stationary bike provision, or a structured mindfulness curriculum. Feasibility and acceptability outcomes will include eligibility, consent, randomization, attendance, retention, questionnaire completion, missing data, and adverse events. Preliminary outcomes will include sleep quality, fatigue, pain, physical activity, mindfulness, motivation for exercise, and quality of life assessed at baseline, immediately post-intervention at week 8, and 3 months post-intervention.",[367,27,368,369,370],"Prostate Cancer","Fatigue","Physical Inactivity","Pain",[367,372,359,373,374,375,376,377,207,378,379,380,381,382,383],"prostate neoplasms","mindfulness","exercise","physical activity","eHealth","sleep quality","fatigue","pain","quality of life","feasibility trial","pilot randomized controlled trial","Hong Kong",{"date":315,"type":34},{"date":386,"type":22},"2026-10-01",{"date":388,"type":22},"2028-09-30",{"name":219,"class":41},{"id":391,"slug":392,"hasResults":12,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":4,"eligibilityCriteria":396,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":228,"enrollmentInfo":397,"targetDuration":4,"studyType":55,"phases":399,"briefSummary":401,"conditions":402,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":405,"completionDateStruct":406,"leadSponsor":408,"locationsCount":104},"100649398","early-phase-1-comparison-between-the-effect-of-two-different-doses-of-oral-melatonin-on-sleep-quality-after-total-hip-arthroplasty-100649398","NCT07732725","Comparison Between the Effect of Two Different Doses of Oral Melatonin on Sleep Quality After Total Hip Arthroplasty","Comparison Between the Effect of Two Different Doses of Oral Melatonin on Sleep Quality After Total Hip Arthroplasty A Randomized Placebo-Controlled Double-Blind Trial","Inclusion Criteria:\n\n* Elective unilateral total hip arthroplasty.\n\nExclusion Criteria:\n\n* Revision arthroplasty\n* documented sleep disorders requiring treatment,\n* use of other sleep medications preoperatively\n* known melatonin allergy or contraindication.",{"count":398,"type":22},150,[400],"EARLY_PHASE1","Considering the fact that melatonin was safely and effectively used in higher doses in multiple surgical conditions , the present study hypothesized that increasing melatonin dose in THA would have better benefits for patients.",[27],"2026-07-26",{"date":315,"type":34},{"date":261,"type":22},{"date":407,"type":22},"2026-11-04",{"name":409,"class":41},"Benha University",{"id":411,"slug":412,"hasResults":12,"nctId":413,"briefTitle":414,"officialTitle":414,"acronym":415,"eligibilityCriteria":416,"healthyVolunteers":12,"sex":17,"minAge":417,"maxAge":418,"enrollmentInfo":419,"targetDuration":4,"studyType":55,"phases":420,"briefSummary":421,"conditions":422,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":430,"locationsCount":322},"100552094","developing-restful-environments-and-management-strategies-for-pediatric-stem-cell-transplant-patients-100552094","NCT06468618","Developing Restful Environments and Management Strategies for Pediatric Stem Cell Transplant Patients","DREAMS","Inclusion Criteria:\n\n* Patient aged 9-17 years.\n* Patient scheduled to receive a stem cell transplant at Boston Children's Hospital.\n* English speaking child and primary caregiver (parent\u002Fguardian).\n\nExclusion Criteria:\n\n-Primary team declines permission to approach.","9 Years","17 Years",{"count":141,"type":22},[57],"Pediatric patients undergoing stem cell transplant (SCT) are hospitalized for extended periods and are at high risk for sleep disturbances. In order to begin to address the environmental issues that SCT recipients face during inpatient hospitalizations, investigators will conduct a single arm pilot study of a program entitled 'Developing Restful Environments and Management Strategies' (DREAMS). The program will provide children receiving SCT and families with information and a kit that includes tools which may support sleep and circadian health during an inpatient hospitalization.",[423,27],"Stem Cell Transplant Complications","2026-07-21",{"date":426,"type":34},"2026-07-22",{"date":428,"type":34},"2024-08-06",{"date":266,"type":22},{"name":431,"class":41},"Dana-Farber Cancer Institute",{"id":433,"slug":434,"hasResults":12,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":438,"eligibilityCriteria":439,"healthyVolunteers":49,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":440,"targetDuration":4,"studyType":55,"phases":442,"briefSummary":443,"conditions":444,"keywords":448,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":104},"100648020","sleep-more-stress-less-90-day-trial-of-neuralli-mood-100648020","NCT07717385","Sleep More, Stress Less: 90-Day Trial of Neuralli Mood","Effects of Neuralli Mood Probiotic Supplementation on Stress, Sleep Disturbance, Mood, and Burnout: A 90-Day Single-Arm Study","NM90","Inclusion Criteria:\n\n* Age 18 years or older and able to provide informed consent.\n* Generally healthy adult experiencing stress, occasional sleep disruption, low mood, anxiety symptoms, or work-related burnout.\n* Willing and able to take two capsules of Neuralli Mood daily for 90 days.\n* Willing and able to complete electronic baseline, follow-up, adherence, and safety assessments.\n* Has reliable access to the internet and an email-enabled device.\n\nExclusion Criteria:\n\n* Pregnant or nursing.\n* Known allergy or hypersensitivity to Neuralli Mood, probiotics, or any product ingredient.\n* Severe or unstable gastrointestinal disease, including a condition for which probiotic use may be inappropriate.\n* Immunocompromised status or current immunosuppressive therapy.\n* Severe or unstable mood disorder, acute psychiatric symptoms, or a current risk of harm to self or others.\n* A clinically significant sleep disorder for which participation or changes in symptoms should be managed by a healthcare professional.\n* Cognitive impairment or another condition that prevents informed consent or reliable completion of study procedures.\n* History of a severe allergic reaction when the investigator determines probiotic use may present an unacceptable risk.\n* Use of a medication or presence of a medical condition for which a healthcare professional advises against probiotic supplementation.\n* Any other circumstance that, in the investigator's judgment, makes participation inappropriate or unsafe.",{"count":441,"type":22},100,[57],"This decentralized, single-arm study evaluates the effects of 90 days of daily Neuralli Mood supplementation on perceived stress, sleep disturbance, mood, anxiety, depressive symptoms, happiness, and occupational burnout in adults experiencing stress or occasional sleep disruption. Participants serve as their own controls, completing validated self-report measures before beginning supplementation and again after the 90-day intervention, with safety and adherence check-ins during the study.",[445,27,446,336,447],"Psychological Stress","Anxiety Symptoms","Occupational Burnout",[449,450,451,452,453,454,455,259,456,457,458],"Neuralli Mood","Probiotic","Postbiotic","Psychobiotic","Gut-brain axis","Lactiplantibacillus plantarum PS128","Lacticaseibacillus paracasei PS23","Sleep","Burnout","Citizen science","2026-07-16",{"date":424,"type":34},{"date":462,"type":34},"2026-06-30",{"date":464,"type":22},"2027-09-28",{"name":466,"class":103},"Efforia, Inc",{"id":468,"slug":469,"hasResults":12,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":4,"eligibilityCriteria":473,"healthyVolunteers":49,"sex":17,"minAge":18,"maxAge":474,"enrollmentInfo":475,"targetDuration":4,"studyType":55,"phases":476,"briefSummary":477,"conditions":478,"keywords":480,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":485,"lastUpdatePostDateStruct":486,"startDateStruct":488,"completionDateStruct":490,"leadSponsor":492,"locationsCount":104},"100560594","pilot-trial-for-health-products-on-mood-and-sleep-quality-100560594","NCT06579183","Pilot Trial for Health Products on Mood and Sleep Quality","A Randomized, Double-blinded, Placebo-controlled Trial to Evaluate Chinese Herbal Medicines, Multivitamins and Amino Acid-containing Supplements on Mood and Sleep Quality","Inclusion Criteria:\n\nParticipants will be eligible for this study if they:\n\n1. are aged 18-65 years;\n2. have basic Chinese and\u002For English reading comprehension and expression abilities, and can complete the questionnaire survey independently; and\n3. are willing and capable of providing signed informed consent; understand and are willing to comply with all study procedures, requirements, and restrictions as listed in the trial protocol and informed consent form; and complete testing and follow-up.\n\nExclusion criteria:\n\nParticipants will be excluded if they:\n\n1. have unstable systemic medical conditions and\u002For surgical history that may limit their participation in the study (e.g., severe organ failure, malignancy, neurological conditions, significant cognitive impairment, history of head trauma or surgery, or kidney, liver, or gastrointestinal conditions that might impair food metabolism);\n2. have a current or past history of an anxiety disorder, major depressive disorder, schizophrenia, bipolar disorder, insomnia, or any other psychiatric illnesses according to the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5);\n3. present suicidal ideation (a score of ≥3 for all questionnaires of the Columbia-Suicide Severity Rating Scale (C-SSRS);\n4. have recent involvement in psychotherapy (e.g., cognitive behavioral therapy, interpersonal psychotherapy, psychodynamic psychotherapy, etc.) and\u002For behavioral interventions 4 weeks prior to and throughout the study; and\u002For use of psychiatric medications (e.g., anxiolytic medications, antidepressant medications, etc.) or medications with central nervous system activation (e.g., anticholinergic drugs, acetylcholinesterase inhibitors, etc.) 12 weeks prior to and throughout the study;\n5. have alcohol abuse (defined as ≥2 drinks per day) or substance abuse;\n6. are pregnant, in lactation, or intend to conceive during the six months preceding the beginning of the trial;\n7. are unwilling to abstain from concomitant unnecessary prescription or over-the-counter medications, herbal extracts, vitamins, dietary supplements, illicit or recreational drugs, or vaccines (except oral contraceptive pills) at least 4 weeks prior to and throughout the study, which might interfere with study outcomes;\n8. have a history of adverse reactions or known allergies to ingredients in the investigational products;\n9. are unable to ingest pills, or\n10. are currently participating in or have participated in a program, treatment plan, or research study involving oral administration of investigational product(s) and\u002For diet, lifestyle modification 4 weeks prior to and throughout the study.","65 Years",{"count":363,"type":22},[57],"This is a pilot, single-site clinical trial that will follow a randomized, double-blinded, parallel-group, placebo-controlled design. A total of 60 participants aged 18-65 will be recruited for a 12-week intervention, followed by a 4-week observational phase and a post-intervention visit at week 16. Participants will attend five scheduled visits at 4-week intervals (baseline, weeks 4, 8, 12, and 16) at the Specialist Clinical Centre for Teaching and Research, School of Chinese Medicine, the University of Hong Kong (HKUSCM). At each visit, assessments will include psychological attributes and sleep quality. Participants will be randomly allocated to one of 2 groups (n=30 per group): the intervention group, which will receive VCMBF and VCDSF, and the control group, which will receive a placebo matched for appearance, smell, and taste. Written informed consent will be obtained from each participant prior to the commencement of the study.\n\nThe primary outcome will be overall mental health, accessed by the Depression, Anxiety and Stress Scale - 21 items (DASS-21). Secondary outcomes will include anxiety status, measured by the Chinese version of the Beck Anxiety Inventory (BAI-C); depression status, measured by the Chinese version of the Beck Depression Inventory-II (C-BDI-II); stress levels, measured by the Perceived Stress Scale (PSS); psychological well-being, measured by the General Health Questionnaire-28 (GHQ-28); quality of life, assessed using the WHOQOL-BREF (Hong Kong version); and sleep quality, assessed using the Pittsburgh Sleep Quality Index (PSQI), the Mi wristband as an objective measure, and the Consensus Sleep Diary (CSD) for cross-validation. Tongue and pulse characteristics will also be recorded for qualitative analysis. Safety profiles of VCMBF and VCDSF will be evaluated throughout the study. Assessments will occur every four weeks until week 16, with tongue and pulse characteristics recorded at baseline, week 12, and week 16. A generalized linear mixed-effect model will be applied to compare outcomes over time in the 2 groups.",[27,479],"Emotional Disturbance",[481,482,207,483,484],"Chinese herbal medicine","supplement","emotional disturbance","mood","2026-07-08",{"date":487,"type":34},"2026-07-10",{"date":489,"type":22},"2026-09",{"date":491,"type":22},"2028-09",{"name":219,"class":41},{"id":494,"slug":495,"hasResults":12,"nctId":496,"briefTitle":497,"officialTitle":498,"acronym":499,"eligibilityCriteria":500,"healthyVolunteers":49,"sex":17,"minAge":18,"maxAge":474,"enrollmentInfo":501,"targetDuration":4,"studyType":55,"phases":503,"briefSummary":504,"conditions":505,"keywords":507,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":511,"startDateStruct":513,"completionDateStruct":515,"leadSponsor":517,"locationsCount":104},"100602112","spark-healthy-sleep-100602112","NCT07119268","SPARK Healthy Sleep","SPARK-Healthy Sleep: A Digital Health Intervention to Promote Behavioral, Emotional, and Cognitive Changes","SPARK","Inclusion Criteria:\n\n* Age ≥18 years\n* Current college enrollment\n* English fluency\n* Prodromal Questionnaire-Brief endorsement score ≥7\n* Pittsburgh Sleep Quality Index score \\>5\n* Pass validity screening questions\n\nExclusion Criteria:\n\n* Previous psychotic disorder diagnosis\n* Unable to provide informed consent",{"count":502,"type":22},115,[57],"SPARK-Healthy Sleep is a digital mental health intervention designed to help college students who may be at risk for psychosis and experience sleep problems. About 1 in 4 college students report psychotic-like experiences (such as hearing voices or feeling paranoid), and these students often have poor sleep quality, which can worsen their mental health symptoms.\n\nThis study tests whether a single-session digital intervention can improve sleep and reduce mental health stigma in at-risk college students. The intervention is delivered through a smartphone app and takes about 30 minutes to complete. It includes educational content about mental health being on a continuum (not just \"normal\" vs \"abnormal\"), strategies to reduce stigma around seeking help, and evidence-based sleep improvement techniques based on cognitive behavioral therapy for insomnia.\n\nThe study will recruit 115 college students from Indiana University-Indianapolis who score high on measures of psychotic-like experiences and poor sleep quality. Half will receive the intervention immediately (experimental group), while the other half will wait three weeks before receiving it (control group). All participants will complete questionnaires about sleep, mental health symptoms, social functioning, and stigma at the beginning of the study and after two weeks.\n\nThe main goals are to determine if the intervention is feasible and acceptable to students, and whether it shows preliminary effectiveness in improving sleep quality, reducing stigma, and improving overall mental health outcomes. A subset of participants will also complete interviews about their experience using the intervention.\n\nThis research addresses important barriers to mental health care for college students, including stigma and limited access to services. If successful, this digital approach could provide a scalable way to help at-risk students improve their mental health and potentially prevent more serious problems from developing.",[506,27],"Schizophrenia and Related Disorders",[339,508,509],"Sleep Disturbances","Psychosis-Spectrum Disorders","2026-07-03",{"date":512,"type":34},"2026-07-07",{"date":514,"type":34},"2025-10-24",{"date":516,"type":22},"2026-10-31",{"name":518,"class":41},"Indiana University",{"id":520,"slug":521,"hasResults":12,"nctId":522,"briefTitle":523,"officialTitle":524,"acronym":525,"eligibilityCriteria":526,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":527,"targetDuration":4,"studyType":55,"phases":529,"briefSummary":530,"conditions":531,"keywords":534,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":537,"lastUpdatePostDateStruct":538,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":104},"100619545","sleep-and-circadian-interventions-for-college-students-at-high-risk-of-suicide-100619545","NCT07346014","Sleep and Circadian Interventions for College Students at High Risk of Suicide","Triple Chronotherapy + Transdiagnostic Sleep and Circadian Intervention (TSC+) for Suicidal Young Adults","REST-UP","Inclusion Criteria:\n\n* Enrolled or planning to enroll in treatment at COSTAR Intensive Outpatient Program\n* English language fluency and literacy sufficient to engage in study protocol\n* Suicidal ideation or suicide attempt in past month\n* Clinically significant sleep disturbance, operationalized as Pittsburgh Sleep Quality Index global PSQI score \\>= 7, and\u002For delayed bedtimes (\\>midnight), and\u002For \\>2 hours in sleep timing variability\n\nExclusion Criteria:\n\n* Non-affective psychosis per electronic health record (EHR) review and\u002For baseline clinical assessment, or symptom severity or psychosocial functioning impairments that preclude participation\n* Contraindications for either sleep deprivation or bright light therapy (e.g., bipolar disorder; seizure disorder; photosensitizing medication)\n* Intellectual disability precluding comprehension of study procedures\n* Evidence of untreated obstructive sleep apnea and\u002For restless legs syndrome\n* Life-threatening medical condition requiring immediate treatment (such as cancer; end stage disease)\n* Pregnancy",{"count":528,"type":22},90,[57],"The purpose of this study is to examine the extent to which delivering sleep and circadian focused interventions in addition to evidenced based psychiatric care for depression and suicide risk may contribute to decreasing suicide risk among high risk young adults. Investigators will evaluate three interventions targeting sleep in acutely suicidal college students enrolled in intensive outpatient treatment. Participants will be randomly assigned to one of three intervention groups:\n\n1. Triple Chronotherapy (TCT)+ Transdiagnostic Sleep and Circadian Intervention (TSC)\n2. Transdiagnostic Sleep and Circadian Intervention (TSC)\n3. Sleep Feedback (SF) Participants will be followed for 6 months with primary outcome domains of suicidal thoughts and behaviors and depression evaluated by blinded clinicians at short (Days 1-4 of intervention), medium (2 months) and long (6 month) term intervals.",[27,456,532,533],"Depression","Suicide",[207,535,536],"suicide","triple chronotherapy","2026-07-02",{"date":512,"type":34},{"date":540,"type":34},"2026-06-18",{"date":542,"type":22},"2029-03",{"name":157,"class":41},{"id":545,"slug":546,"hasResults":12,"nctId":547,"briefTitle":548,"officialTitle":548,"acronym":4,"eligibilityCriteria":549,"healthyVolunteers":49,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":550,"targetDuration":4,"studyType":55,"phases":551,"briefSummary":552,"conditions":553,"keywords":556,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":563,"startDateStruct":565,"completionDateStruct":567,"leadSponsor":568,"locationsCount":104},"100519625","automated-assistive-non-contact-sleep-quality-monitor-for-individuals-with-alzheimers-disease-100519625","NCT06045988","Automated, Assistive, Non-Contact Sleep Quality Monitor for Individuals With Alzheimer's Disease","Inclusion Criteria:\n\n* Diagnosis of Alzheimer's Disease (AD) or Alzheimer's Disease Related Dementias (ADRD)\n* Residents of long-term care (LTC) facility study site location for a minimum of 30 days.\n* Willingness to consent to study or when a potential participant lacks decision making capacity (determined by LTC facility clinical provider) willingness of a Legally Authorized Representative (LAR) to consent to study participation on potential participant's behalf.\n\nExclusion Criteria:\n\n* Currently on hospice",{"count":441,"type":22},[57],"This study seeks to evaluate the utility and efficacy of the Non-Contact Sleep Quality Monitor System when used to monitor the sleep quality of individuals living in long-term care (LTC) with either Alzheimer's Disease (AD) or Alzheimer's Disease Related Dementia (ADRD). This before-after comparison trial will be conducted in several LTC facilities to evaluate the effect access to System Sleep Quality Data has on documentation of sleep disorders or treatments and sleep quality change over time for AD\u002FADRD participants in the intervention group as compared to the control group.\n\nAll subjects will undergo sleep quality monitoring for 4-weeks. At the end of the first 2-weeks, research staff and LTC facility staff and medical providers will receive access to sleep monitoring data. We hypothesize that when real-time System Sleep Data is shared with LTC staff or healthcare providers, that sleep disturbances will be more readily detected, leading to timelier, better tailored treatment interventions for sleep disturbances, thereby improving sleep quality and decreasing daytime physical inactivity.",[554,555,27],"Alzheimer Disease","Dementia",[557,558,559,555,560,561],"Sleep Assessment","Sleep Disorder","Technology","Long-Term Care","Sleep Monitoring","2026-06-23",{"date":564,"type":34},"2026-06-26",{"date":566,"type":22},"2026-07",{"date":155,"type":22},{"name":518,"class":41},{"id":570,"slug":571,"hasResults":12,"nctId":572,"briefTitle":573,"officialTitle":574,"acronym":4,"eligibilityCriteria":575,"healthyVolunteers":49,"sex":17,"minAge":18,"maxAge":576,"enrollmentInfo":577,"targetDuration":4,"studyType":55,"phases":579,"briefSummary":580,"conditions":581,"keywords":583,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":593,"locationsCount":104},"100524487","a-stepped-care-model-to-deliver-cbt-i-in-community-100524487","NCT06109363","A Stepped Care Model to Deliver CBT-I in Community","Effectiveness of a Stepped Care Model to Deliver Cognitive-behaviour Therapy for Insomnia in Adults, a Pragmatic Stepped-wedge Cluster Randomized Trial","Inclusion Criteria:\n\n1. Chinese adults aged 18-70 years old,\n2. The score of Insomnia Severity Index ≥ 10.\n\nExclusion Criteria:\n\n1. present with psychotic disorders such as bipolar disorder and schizophrenia,\n2. present with severe depression or suicidal ideation,\n3. present with neurodegenerative diseases that prevent participant from completing the intervention (e.g., dementia and Parkinson's disease).\n4. unable to provide consent","70 Years",{"count":578,"type":22},1100,[57],"Insomnia is one of the most common sleep disorders and affects approximately 10 - 40% of the population across different age groups in Hong Kong. Cognitive behavioral therapy for insomnia (CBT-I) is the first line treatment for adult insomnia due to its comparable effect to medication in short term but is more sustainable in the long run. However, only a few sufferers have received CBT-I, due to limited accessibility, lack of trained sleep therapists, time costing and geographical limitations. To increase CBT-I accessibility, different formats of CBT-I have been proposed. Empirical evidence including ours consistently suggested that self-help digital CBT-I is effective in improving sleep while its augmentation with a guided approach could further enhance the treatment gain. Previous evidence has suggested that although self-help CBT-I could lead to positive outcomes, the drop out rate is quite high and maybe less effective for patients with comorbidity or high level of distress.\n\nThus, a stepped-care approach to CBT-I that utilizes online self help and therapist-guided modes of delivery might be a potential way to facilitate efficient dissemination of effective insomnia treatment resources. The effectiveness of the stepped care model will be evaluated in a real world setting using stepped-wedge cluster randomized controlled design. The program will be rolled out to different districts in Hong Kong sequentially in 18 districts over 4 steps with a eqaully spaced time periods.",[582,27],"Insomnia",[582,584,585],"Stepped care model","Stepped wedge cluster randomized trial","2026-06-19",{"date":588,"type":34},"2026-06-24",{"date":590,"type":34},"2023-10-23",{"date":592,"type":22},"2027-04-22",{"name":594,"class":41},"Chinese University of Hong Kong",{"id":596,"slug":597,"hasResults":12,"nctId":598,"briefTitle":599,"officialTitle":600,"acronym":4,"eligibilityCriteria":601,"healthyVolunteers":49,"sex":17,"minAge":602,"maxAge":474,"enrollmentInfo":603,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":604,"conditions":605,"keywords":609,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":618,"startDateStruct":619,"completionDateStruct":620,"leadSponsor":622,"locationsCount":104},"100644217","non-invasive-sleep-monitoring-for-burnout-and-retention-risk-in-postgraduate-nurses-100644217","NCT07666633","Non-Invasive Sleep Monitoring for Burnout and Retention Risk in Postgraduate Nurses","Development of a Non-Invasive Sleep-Based Prediction Platform for Burnout and Retention Risk Among Postgraduate Nurses: A Psychophysiological and AI-Driven Approach for High-Stress Clinical Populations","Inclusion Criteria:\n\n* Newly employed postgraduate nurses within the first 3 months of clinical practice\n* Age 20 to 65 years\n* Full-time clinical nursing staff\n* Able to read and complete Chinese questionnaires\n* Willing to participate in repeated psychological assessments and non-invasive sleep monitoring\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Diagnosed severe sleep disorders\n* Diagnosed severe psychiatric disorders\n* Current use of medications that significantly affect sleep or autonomic nervous system function\n* Inability to comply with longitudinal follow-up procedures\n* Inability to complete repeated sleep monitoring assessments","20 Years",{"count":441,"type":22},"Newly graduated nurses often experience high levels of psychological stress, sleep disturbance, fatigue, and burnout during the early transition into clinical practice. Early identification of burnout and retention risk may help improve mental well-being, workforce stability, and quality of patient care.\n\nThis longitudinal observational study aims to develop a non-invasive sleep-based prediction platform for assessing burnout and retention risk among postgraduate nurses. Participants will undergo repeated psychological assessments and non-contact sleep monitoring during the study period. Sleep-related physiological parameters, including sleep efficiency, sleep structure, heart rate variability, and respiratory variability, will be collected together with validated psychological questionnaires.\n\nThe study will further apply machine learning and artificial intelligence approaches to integrate longitudinal physiological and psychological data for risk prediction and early identification of burnout-related conditions. The findings may support future development of precision mental health monitoring and supportive management strategies for high-stress healthcare workers.",[457,27,606,607,608,368],"Occupational Stress","Mental Health","Nurse Retention",[610,611,612,613,614,615,122,616,617,445],"Postgraduate Nurses","Non-Invasive Sleep Monitoring","Burnout Risk","Retention Risk","Artificial Intelligence","Machine Learning","Heart Rate Variability","Shift Work",{"date":588,"type":34},{"date":293,"type":22},{"date":621,"type":22},"2027-04-23",{"name":623,"class":41},"Kaohsiung Armed Forces General Hospital",{"id":625,"slug":626,"hasResults":12,"nctId":627,"briefTitle":628,"officialTitle":629,"acronym":630,"eligibilityCriteria":631,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":632,"targetDuration":4,"studyType":55,"phases":634,"briefSummary":635,"conditions":636,"keywords":640,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":645,"lastUpdatePostDateStruct":646,"startDateStruct":648,"completionDateStruct":650,"leadSponsor":651,"locationsCount":104},"100631270","weighted-blanket-use-for-adults-with-chronic-pain-100631270","NCT07498491","Weighted Blanket Use for Adults With Chronic Pain","A Single-Arm Pilot Study Investigating Weighted Blanket Use for Chronic Pain","EMBRACE","Inclusion Criteria:\n\n* Age: Male and non-pregnant female adult participants must 18 years of age or older\n* Duration of pain: at least 3 months\n* Average Pain Intensity over the past week: ≥3\u002F10 NRS\n* Safely able to lift a weighted blanket that is 10% of the participant's self-reported body weight (10-25 lbs.) without assistance.\n* Willing to sleep with a weighted blanket (10-25 lbs.) for a total of 35 (7 days for Run-In\u002FAdjustment + 28 days of trial).\n* Willing to maintain current dietary patterns, activity level, and stable body weight for the duration of the study.\n* Willing to undergo study procedures, including completion of online questionnaires and surveys, and attend virtual study visits.\n* Informed Consent: Participants must be able to provide informed consent and comply with the study procedure.\n* Able to speak, read, and understand English.\n* Able to access WIFI to attend virtual visits and complete study surveys.\n\nExclusion Criteria:\n\n* Age: Participants younger than 18 years old.\n* Currently using a weighted blanket (will have opportunity for washout period)\n* Inability to lift a 10-25 lbs. (10% of body weight) weighted blanket without assistance.\n* Inability or unwillingness to sleep with the weighted blanket nightly\n* Breathing\u002FRespiratory Issue: Obstructive sleep apnea (OSA), Chronic obstructive Pulmonary Disease (COPD- includes emphysema and chronic bronchitis), Tuberculosis (TB), severe asthma\n* Cancer: Lung cancer\n* Cardiovascular Disease: Congestive heart failure (CHF), severe cardiomyopathy\n* Circulatory Issues: Severe peripheral artery disease (PAD), severe or uncontrolled Type 2 Diabetes\n* Recent surgery: Participants who recently had surgery and\u002For have an open wound.\n* Pregnancy or Lactation: Individuals who are pregnant, lactating, or planning a pregnancy within the next 35 days.\n* Co-sleeping: Individuals who co-sleep with their infant or young child.\n* Allergies: Known allergy or hypersensitivity to any component of the study products (including cotton material, natural and plant-based dyes).\n* Claustrophobia\n* Participation in Other Pain Trials: Currently participating in another pain research study.\n* Any condition that, in the opinion of the Investigator, does not justify the individuals' participation in the study that may impact their safety or confound trial results. This includes an increase in the participants' pain intensity during the baseline week or the active part of the trial.",{"count":633,"type":22},44,[57],"Chronic pain is a common condition that can affect sleep, daily functioning, and overall quality of life. Many individuals living with chronic pain seek non-medication approaches to help manage their symptoms. Weighted blankets are commonly used to promote relaxation and comfort during sleep, but there is limited research examining their potential role in supporting people with chronic pain.\n\nThis pilot study will explore the experiences of adults with chronic pain who use a weighted blanket during sleep. The study aims to better understand whether nightly use of a weighted blanket may be associated with changes in pain, sleep, and daily functioning. Findings from this study will help inform future research on non-medication approaches to managing chronic pain.\n\nApproximately 44 adults with chronic pain will participate in the study. Participation will last about five weeks. After completing a virtual enrollment visit and baseline questionnaires, participants will receive a weighted blanket sized to approximately 10 percent of their body weight.\n\nParticipants will first complete a 7-day adjustment period using the blanket while sleeping. If they tolerate the blanket and use it nightly during this period, they will continue into a 4-week study phase in which they will use the weighted blanket each night.\n\nDuring the study, participants will complete brief online surveys about their experiences and adherence to using the blanket. Pain and quality-of-life questionnaires will be completed at multiple time points, including at the start and end of the study. Participants will also provide feedback about their experience using the weighted blanket.\n\nResults from this pilot study will help researchers better understand how weighted blankets may be used by adults with chronic pain and may help guide the design of future studies evaluating non-pharmacologic approaches to pain management.",[637,638,27,639],"Chronic Pain","Musculoskeletal Pain","Pain Disorders",[641,180,642,643,644],"chronic pain","pain management","non-pharmacologic pain management","sleep intervention","2026-06-15",{"date":647,"type":34},"2026-06-17",{"date":649,"type":34},"2026-05-27",{"date":318,"type":22},{"name":652,"class":41},"National University of Natural Medicine",{"id":654,"slug":655,"hasResults":12,"nctId":656,"briefTitle":657,"officialTitle":658,"acronym":659,"eligibilityCriteria":660,"healthyVolunteers":12,"sex":17,"minAge":661,"maxAge":4,"enrollmentInfo":662,"targetDuration":4,"studyType":55,"phases":663,"briefSummary":665,"conditions":666,"keywords":668,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":645,"lastUpdatePostDateStruct":673,"startDateStruct":674,"completionDateStruct":676,"leadSponsor":678,"locationsCount":104},"100460970","phase-2-targeting-cognition-in-early-alzheimers-disease-by-improving-sleep-with-trazodone-100460970","NCT05282550","Targeting Cognition in Early Alzheimer's Disease by Improving Sleep With Trazodone","RCT Targeting Cognition in Early Alzheimer's Disease by Improving Sleep With Trazodone (REST)","REST","Inclusion Criteria:\n\n1. Mild Cognitive Impairment (MCI) as defined by Albert et al.2 including subjective memory complaint and\u002For objective evidence of memory problems;\n2. Clinical Dementia Rating (CDR) of 0.5 with a Memory Box score of \\>=0.5;\n3. Evidence of sleep complaints with Pittsburgh Sleep Quality Index score of \\>5 (a well-validated cutoff observed in \\>40% of older persons);\n4. Memory performance \\> 1.5 Standard Deviation (SD) below age-and education-matched control subjects on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) List Recall;\n5. Visual and auditory acuity adequate for neuropsychological testing;\n6. Good general health with no disease expected to interfere with the study;\n7. Able to have Magnetic Resonance Imaging (MRI) scan;\n8. Availability of knowledgeable informant (KI)\n9. Buschke Selective Reminding Test or more standard deviations below age-education norms\n\nExclusion Criteria:\n\n1. Less than 55 years of age to reduce likelihood of including individuals with frontotemporal dementia or non-dementia MCI;\n2. Too frail or medically unstable to undergo study procedures;\n3. Prior diagnosis of Obstructive Sleep Apnea (OSA) or evidence of moderate-to-severe OSA on baseline Home Sleep Test (HST) as evidenced by an apnea\u002Fhypopnea index of \\>15;\n4. Dementia;\n5. Cognitive complaints and deficits better explained by other medical\u002Fneurologic conditions;\n6. Delirium;\n7. Allergic to trazodone;\n8. Taking sleep medications including trazodone;\n9. Current substance abuse;\n10. Current major depressive, manic, or acute psychotic episode;\n11. Prior diagnosis of significant systemic illness or unstable medical condition which could lead to difficulty complying with the study protocol or represent alternate primary cause of memory problems beyond Alzheimer's Disease (AD) pathology:\n12. Lack of available KI;\n13. Prior diagnosis of Q wave T wave Corrected for heart rate (QTc) \\> 470 msec (females) or \\> 450 msec (males);\n14. Inability to provide informed consent","55 Years",{"count":441,"type":22},[664],"PHASE2","To investigate the effect of trazodone on sleep, hippocampal-dependent memory and hippocampal excitability. The investigators hypothesize that trazodone will improve total sleep time and proportion of time in Slow Wave Sleep (SWS).",[667,27],"AMCI - Amnestic Mild Cognitive Impairment",[669,670,671,672],"AMCI","Slow wave sleep","Trazodone","Cognition",{"date":647,"type":34},{"date":675,"type":34},"2023-02-02",{"date":677,"type":22},"2028-06-30",{"name":679,"class":41},"Johns Hopkins University",{"id":681,"slug":682,"hasResults":12,"nctId":683,"briefTitle":684,"officialTitle":685,"acronym":4,"eligibilityCriteria":686,"healthyVolunteers":49,"sex":17,"minAge":87,"maxAge":88,"enrollmentInfo":687,"targetDuration":4,"studyType":55,"phases":689,"briefSummary":690,"conditions":691,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":694,"lastUpdatePostDateStruct":695,"startDateStruct":696,"completionDateStruct":698,"leadSponsor":700,"locationsCount":104},"100641383","radicle-energy-vbmtm-a-study-assessing-the-impact-of-health-and-wellness-products-on-fatigue-and-related-health-outcomes-100641383","NCT07653724","Radicle Energy VBMTM: A Study Assessing the Impact of Health and Wellness Products on Fatigue and Related Health Outcomes","Radicle Energy VBMTM: A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Impact of Health and Wellness Products on Fatigue and Related Health Outcomes","Participants must meet all the following criteria:\n\n* Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities\n\n  * Assigned sex at birth will determine sex-specific recruitment and PROs (male vs female) employed, when needed\n* Resides in the United States\n* Has the opportunity for at least 30% improvement in their primary health outcome\n* Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study\n\n3.2 Exclusion\n\nIndividuals who report any of the following during screening may be excluded from participation:\n\n* Report being pregnant, trying to become pregnant, or breastfeeding\n* Unable to provide a valid US shipping address and mobile phone number\n* Reports current enrollment in another clinical trial\n* Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)\n* Unable to read and understand English at a 7th grade level\n* Reports a current and\u002For recent (up to 3 months ago) major illness and\u002For surgery that poses a known, significant safety risk.\n* Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known contraindication and\u002For a significant safety risk with any of the study product ingredients.\n\n  * NYHA Class III or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure\n* Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients.\n\n  * Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs, or thyroid products\n* Reports current use of caffeine-alternative products\n* Reports consuming 3 or more caffeinated beverages a day\n* Lack of reliable daily access to the internet",{"count":688,"type":22},550,[57],"Radicle Energy VBMTM: A randomized, double-blind, placebo- controlled direct-to-consumer study assessing the impact of health and wellness products on fatigue and related health outcomes.",[368,692,693,27],"Cognitive Function","Global Mental Health","2026-06-12",{"date":647,"type":34},{"date":697,"type":22},"2026-06-25",{"date":699,"type":22},"2027-06-25",{"name":102,"class":103}]