[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sleep-problems\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sleep-problems":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,48,71,95,117,148,178,213,235,256,285,310,352,373,394],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100649493","evaluation-of-a-couple-based-psycho-socio-educational-intervention-using-wechatwhatsapp-on-dyadic-psychological-and-sleep-outcomes-100649493",false,"NCT07736378","Evaluation of a Couple-based Psycho-socio-educational Intervention Using WeChat\u002FWhatsApp on Dyadic Psychological and Sleep Outcomes","Evaluation of a Couple-based Psycho-socio-educational Intervention Using WeChat\u002FWhatsApp on Dyadic Psychological and Sleep Outcomes: A 3-armed Randomised Controlled Trial","WeLove RCT","Inclusion:\n\n* pregnant women over the age of 18\n* pregnant women's partners over the age of 18\n* women with a gestation of 12 to 28 weeks\n* women and their partners can read and understand Chinese\n* women and their partners possess electronic devices equipped with WhatsApp or WeChat\n* women and their partners can provide written informed consent.\n\nExclusion:\n\n* pregnant women and\u002For partners with current severe medical illnesses\n* women and\u002For their partners with psychological problems\n* women and\u002For their partners with sleep disorders",true,"ALL","18 Years",{"count":21,"type":22},336,"ESTIMATED","INTERVENTIONAL",[25],"NA","Background: Pregnancy is a challenging time, and couples frequently experience psychological and sleep problems. Despite the dyadic effects of these problems, most interventions have focused on pregnant women alone, not on couples. The research team developed an innovative intervention targeting couples during pregnancy to fill the research gaps.\n\nObjectives: (1) examine the effects of couple-based psycho-socio-educational intervention using WeChat\u002FWhatsApp (WeLove) on dyadic psychological symptoms (depression, anxiety, stress symptoms), sleep quality, and life satisfaction with wearable data (stress, heart rate, and sleep quality) immediately after the intervention, with follow-up assessments at 3 months and 12 months after the intervention; and (2) examine the interdependence between psychological symptoms and sleep quality in pregnant women and their partners.\n\nMethods: WeLove is a 6-week online intervention through WeChat\u002FWhatsApp based on theoretical and evidence-based support. A three-arm double-blind randomized controlled trial will be used among 336 couples. Participants will be assigned to one of three groups and 112 couples per group: intervention 1 (couples for WeLove), intervention 2 (pregnant women for WeLove), or the control group (use WeChat\u002FWhatsApp as normal). Participants will be assessed pre- and post-intervention, with follow-up assessments at 3 months and 12 months after the intervention. Generalized estimating equation analysis and thematic analysis will be performed to examine the research objectives.\n\nPotential contributions: The findings will provide a cost-effective way to improve psychological and sleep outcomes in couples. Policymakers can use the study's results as evidence to consider an innovative intervention that aims to improve antenatal services in Hong Kong.",[28,29,30],"Sleep Problems","Psychological","Well-Being, Psychological",[32,33,34,35],"Couple-based intervention","Psycho-socio-educational intervention (WeLove)","Psychological well-being","Sleep outcome","NOT_YET_RECRUITING","2026-07-29",{"date":39,"type":40},"2026-07-30","ACTUAL",{"date":42,"type":22},"2026-07-16",{"date":44,"type":22},"2030-07-14",{"name":46,"class":47},"Chinese University of Hong Kong","OTHER",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100648345","generative-ai-for-sleep-promotion-100648345","NCT07718750","Generative AI for Sleep Promotion","Inclusion Criteria:\n\n* Aged 18-75 years\n* had a raw score of 23 or higher on the Patient-Reported Outcomes Measurement Information System (PROMIS™) Sleep Disturbance\n* had a smartphone and be able to access the internet\n* willing and able to participate through text messages on a smartphone\n* able to read and understand English\n\nExclusion Criteria:\n\n* pregnant or lactating\n* concurrently participating in other research studies focused on lifestyle modifications","75 Years",{"count":56,"type":22},60,[25],"Sleep is a major public health concern in the United States. Major guidelines recommend that adults obtain at least 7 hours of sleep per night. More than 25% of U.S. adults do not meet this recommendation, and 14.5% report difficulty falling asleep on most days or every day during the past month. The investigators developed a low-cost, easily accessible sleep intervention using artificial intelligence (AI) technologies. The purpose of this study is to examine the effect of this intervention on sleep outcomes among U.S. adults.",[28],"RECRUITING","2026-07-20",{"date":63,"type":40},"2026-07-22",{"date":65,"type":40},"2025-10-01",{"date":67,"type":22},"2027-12-31",{"name":69,"class":47},"New York University",2,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":18,"minAge":78,"maxAge":19,"enrollmentInfo":79,"targetDuration":4,"studyType":23,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":70},"100616311","sleep-treatment-for-teens-rct-phase-100616311","NCT07303959","Sleep Treatment for Teens (RCT Phase)","Sleep Treatment for Teens","Inclusion:\n\n1. Age 14-18 years old.\n2. Recent hospitalization due to suicide risk (i.e., suicide attempts, aborted\u002Finterrupted attempts, or suicide ideation with intent and\u002For a plan) using an abbreviated version of the semi-structured and well-validated Columbia Suicide Severity Rating Scale (C-SSRS; Posner et al., 2011). Regarding recency, adolescents will need to complete the baseline within three months (Study 1) or 45 days (Study 2) of discharge in order to capture the high-risk post-discharge period, which is up to 3 months following discharge from acute psychiatric hospitalization (Chung et al., 2017).\n3. Clinically significant insomnia symptoms: SCI scores ≤16 will be used to recruit a sample with clinically significant insomnia symptoms. The ISI will also be administered to gain additional information about the nature of adolescents' sleep problems in order to confirm primary insomnia. ISI scores may also be obtained via chart review when applicable\n4. Access to or willingness to use a compatible Smart Device. SleepioTM works with any internet connection (cellular or Wifi) on any iOS device running iOS 10.3 or later or on any Android device running Android OS 8.0 or later. Metricwire is compatible with all devices that SleepioTM is compatible with. If an interested adolescent does not have access to their own smart device, the research team will offer them a loaner device for the duration of the treatment\u002Ffollow-up phase.\n\nAdolescents will be excluded based on the following exclusion criteria:\n\n1. Prior CBT-I treatment, which would indicate lack of response to a prior reasonable dose of this treatment.\n2. Bipolar disorder given that certain components of CBT-I (e.g., sleep restriction) may be risky for this population.\n3. Substance use disorder that is primary to insomnia which would require alternative treatment.\n4. Presence of factors that may reduce participants' ability to consent or complete the study procedures (e.g., current psychosis, other-directed violence; severe cognitive impairment, non-English speaking).\n5. Unwillingness to wear wrist actigraphy or complete the EMA surveys.\n6. Not having a parent willing to provide permission (if participant is a minor) or to consent to their own participation (required for all adolescents). Eligibility will not be based on biological sex, gender identity, race, or ethnicity. These variables will be assessed during screening to compare those who are and are not eligible.\n7. Having a sibling who has enrolled in the study.","14 Years",{"count":80,"type":22},80,[25],"The purpose of this research study is to compare (vs. treatment as usual) a brief (6-session), empirically supported, and highly disseminable version of digital (i.e., smartphone or web-based) cognitive behavioral therapy for insomnia (dCBT-I), called SleepioTM, in suicidal adolescents with co-occurring insomnia during the high-risk post-hospitalization period. Suicide is the 2nd leading cause of death among adolescents. Sleep problems, such as insomnia symptoms-the most common sleep problem in youth-may be a particularly promising treatment target to reduce suicide risk in adolescents. The investigators propose to test the feasibility, acceptability, and effectiveness of dCBT-I in a two-site (Rutgers and Old Dominion University) pilot study trial. Adolescents, 14-18 years-old, recently hospitalized for suicide risk with co-occurring insomnia (n=80, 50% at each site), will receive either dCBT-I (six weekly, 20-minute sessions) plus post-hospitalization treatment-as-usual (TAU) or TAU alone. Adolescents will complete assessments pre-treatment, during the treatment phase including at the end of treatment, and 1-month follow-up post-treatment.",[28,84,85],"Suicidal Ideation","Suicidal Behavior","2026-07-08",{"date":88,"type":40},"2026-07-10",{"date":90,"type":40},"2025-06-02",{"date":92,"type":22},"2026-12-31",{"name":94,"class":47},"Rutgers, The State University of New Jersey",{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":114,"locationsCount":116},"100640099","metabolomics-and-biomarker-research-on-the-mechanism-of-preoperative-sleep-disorders-affecting-postoperative-outcomes-in-cardiac-surgery-patients-100640099","NCT07588178","Metabolomics and Biomarker Research on the Mechanism of Preoperative Sleep Disorders Affecting Postoperative Outcomes in Cardiac Surgery Patients","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Scheduled for elective cardiac surgery\n\nExclusion Criteria:\n\n1. Has a history of neurosurgery, or has suffered from neurological diseases such as cerebral hemorrhage, cerebral infarction, delirium, dementia, etc.\n2. Has a history of mental disorders.\n3. Heavy alcohol consumption.\n4. American Society of Anesthesiologists (ASA) classification level IV or above.\n5. Complicated with severe liver dysfunction (Child-Pugh C grade) or renal dysfunction (chronic kidney disease stage 3-4).\n6. Unable to communicate due to hearing or language problems, or refuses to sign the informed consent form.","80 Years",{"count":103,"type":22},144,"OBSERVATIONAL","This study is titled \"Metabolomics and Biomarker Research on the Mechanism of Preoperative Sleep Disorders Affecting Postoperative Outcomes in Adult Cardiac Surgery\". It aims to clarify the perioperative metabolic changes caused by preoperative sleep disorders in adult cardiac surgery patients, providing ideas for exploring the mechanism by which sleep disorders affect adverse outcomes after cardiac surgery. The study will be conducted at Fuwai Hospital, Chinese Academy of Medical Sciences. By collecting perioperative blood and fecal samples from adult cardiac surgery patients with and without preoperative sleep disorders, and simultaneously recording postoperative clinical outcome indicators (such as the incidence of delirium within 7 days after surgery, cognitive function scores, mechanical ventilation time, ICU stay time, hospital stay time, and severe cardiovascular adverse events), the study will explore the impact of preoperative sleep disorders on perioperative plasma metabolic substances, inflammatory levels, nerve damage, oxidative stress levels, and intestinal flora in adult cardiac surgery patients under general anesthesia, providing ideas and evidence for exploring the mechanism by which preoperative sleep disorders affect postoperative outcomes in adult cardiac surgery patients under general anesthesia.",[107,28],"Delirium - Postoperative","2026-05-08",{"date":110,"type":40},"2026-05-14",{"date":112,"type":40},"2026-01-01",{"date":92,"type":22},{"name":115,"class":47},"Yan Fuxia",1,{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":18,"minAge":124,"maxAge":19,"enrollmentInfo":125,"targetDuration":4,"studyType":23,"phases":127,"briefSummary":130,"conditions":131,"keywords":133,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":116},"100597667","phase-1-a-clinical-trial-of-iron-supplementation-for-youth-with-adhd-and-restless-sleep-100597667","NCT07061470","A Clinical Trial of Iron Supplementation for Youth With ADHD and Restless Sleep","RestEaze: A Novel Wearable Device and Mobile Application to Improve the Diagnosis and Management of Restless Sleep in Pediatric Patients With Attention Deficit\u002FHyperactivity Disorder, Phase II","Inclusion Criteria:\n\n* clinically diagnosed with ADHD\n* have blood ferritin level below 50ng\u002FmL\n* have parent- or self-reported restless sleep\n\nExclusion Criteria:\n\n* presence of any chronic medical or genetic condition that could impact iron metabolism\n* presence of moderate to severe Obstructive Sleep Apnea\n* having received Iron supplementation treatment within the past 3 months\n* having blood ferritin level indicative of anemia that requires immediate treatment","8 Years",{"count":126,"type":22},70,[128,129],"PHASE1","PHASE2","The goal of this clinical trial is to learn if iron supplementation works to restless sleep in youth with ADHD. A second goal is to learn if iron supplementation helps to ease ADHD symptoms. The main questions that this trial aims to answer are:\n\nDoes 3 months of iron supplementation treatment improve parent- and youth self-reported sleep difficulties more than placebo? Does 3 months of iron supplementation treatment improve sleep as measured by actigraphy more than placebo? Does 3 months of iron supplementation treatment improve parent-reported and\u002For objectively measured attention more than placebo?\n\nResearchers will compare over-the-counter iron supplementation treatment to a placebo (a look-alike substance that contains no drug) to see if iron supplementation works to treat sleep difficulties in youth with ADHD.\n\nParticipants will:\n\n* Take iron supplements every day for 3 months\n* Visit the clinic once before treatment begins and once at the end of treatment to complete tests and rating scales related to sleep and attention\n* Wear motion-monitoring leg bands while sleeping for one 2-week period before treatment begins and one 2-week period at the end of treatment",[132,28],"ADHD",[132,134,135,136,137,138],"iron supplements","sleep","restlessness","attention","restless legs syndrome","2026-04-30",{"date":141,"type":40},"2026-05-04",{"date":143,"type":22},"2027-03-01",{"date":145,"type":22},"2027-07-31",{"name":147,"class":47},"Hugo W. Moser Research Institute at Kennedy Krieger, Inc.",{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":155,"enrollmentInfo":156,"targetDuration":4,"studyType":23,"phases":157,"briefSummary":158,"conditions":159,"keywords":161,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":116},"100575166","the-impact-of-melatonin-lotion-on-sleep-and-mental-health-100575166","NCT06768749","The Impact of Melatonin Lotion on Sleep and Mental Health","The Impact of Melatonin Lotion on Actigraphy, Sleep Quality, Autonomic Nervous System Indicators, Mood, Anxiety Symptoms, and Side Effects","Inclusion Criteria:\n\n* a T score ≥ 48 on the sleep disturbance short form Patient-Reported Outcomes Measurement Information System (PROMIS) measure, and\n* a T score ≥ 55 on the anxiety or depression short form PROMIS measures (mild symptoms or more)\n\nExclusion Criteria:\n\n* currently using antidepressant, anti-anxiety, or sleep medication including melatonin\n* are pregnant\n* have allergies\u002Fsensitivities to scented lotion\n* are unwilling to commit to keeping a similar bedtime (± 1 hour) during treatment weeks.","21 Years",{"count":56,"type":22},[25],"The purpose of this study is to examine the effect that melatonin lotion has on sleep quality, the nervous system, and mental health. Melatonin is a hormone secreted by the brain that regulates sleep and might improve depression and anxiety symptoms. The goal is to determine whether melatonin in lotion form is an effective treatment for young adults with inadequate sleep and might improve mental health. Participants will fill out surveys, wear an actigraph (a wrist-worn device that measures sleep), wear a heart rate monitor (a strap worn around one's chest), and provide nightly saliva samples during treatment weeks. In one of the two treatment weeks, participants will receive a lotion that contains melatonin. During the other week they will receive a control treatment that will be lotion with no melatonin, and there will be a week in between with no treatment at all.",[28,160],"Depressive Disorder and Anxiety Disorders",[162,135,163,164,165,166,167,168],"melatonin","heart rate variability","actigraphy","amylase","mood","anxiety","depression","2026-04-27",{"date":171,"type":40},"2026-05-01",{"date":173,"type":40},"2025-02-28",{"date":175,"type":22},"2028-04-01",{"name":177,"class":47},"University of Redlands",{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":18,"minAge":185,"maxAge":186,"enrollmentInfo":187,"targetDuration":4,"studyType":23,"phases":189,"briefSummary":190,"conditions":191,"keywords":193,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":116},"100606901","sleep-and-blankets-100606901","NCT07181577","Sleep and Blankets","SWAN","Inclusion Criteria:\n\n* Participants must be between 16 and 24 years old\n* Participants must have a score on the Insomnia Severity Index (ISI) above 10.\n\nExclusion Criteria:\n\n* Presence of neurological disorders known to influence or be related to poor sleep including affective disorders and diagnosed medical sleep disorders (e.g., sleep apnea, narcolepsy)\n* Circulatory or respiratory disease\n* Pregnancy, shift or night work\n* Prior use of special blanket (within the past five years)\n* Insufficient Danish proficiency.","16 Years","24 Years",{"count":188,"type":22},672,[25],"Purpose\n\nThe primary aim of this research project is to evaluate whether a special blanket is an effective intervention for improving sleep among young people aged 16-24 with sleep disturbances. Sleep problems are increasingly common among Danish youth, with approximately one in five reporting significant sleep difficulties in the past 14 days. This trend has been rising steadily since 2010 and is mirrored internationally. Sleep disturbances are linked to a wide range of physical and mental health problems, including stress, anxiety, and depression, as well as negative effects on academic performance and social relationships. Early intervention is crucial to prevent chronic insomnia and poor mental health outcomes in adulthood.\n\nCurrent treatments include specialized psychological therapies and medication. However, psychological therapies require extensive time and commitment, and medication carries risks of side effects, tolerance, and dependency, making non-pharmacological, safe, and accessible alternatives necessary. The special blanket is believed to promote relaxation through stimulation of the tactile and proprioceptive systems. Although promising in clinical and pedagogical contexts for certain populations (e.g., children with developmental disorders and adults with neurological conditions), there is limited scientific evidence regarding its efficacy and underlying mechanisms, particularly among youth with sleep disturbances.\n\nMethods and Study Design\n\nThis project is a Phase 1 randomized controlled trial (RCT) assessing the effect of 4 weeks of using a special blanket on sleep problems among young people aged 16-24, as well as the impact on participants' mental and physical health. Additionally, the study investigates possible stress-related mechanisms involved in the use of the special blanket. Following the 4-week intervention, an open-label extension phase of 8 weeks (Phase 2) will explore continued use and acceptability of the blanket.\n\nEligible participants, screened for sleep problems, will be randomly assigned to one of three groups:\n\nGroup 1: receives a special blanket (Blanket A) for home use over 4 weeks.\n\nGroup 2: receives another special blanket (Blanket B) for 4 weeks.\n\nGroup 3 (observation group): no blanket provided but followed for 4 weeks to monitor changes in sleep problems.\n\nThe 4-week intervention phase (Phase 1) includes baseline (T1, week 0), mid-intervention (T2, week 2), and post-intervention (T3, week 4) online assessments. Sleep disturbances, physical and mental health, and stress-related mechanisms will be measured using validated questionnaires administered through REDCap. The first 40 participants in Groups 1 and 2 will additionally provide saliva samples and wear a circadian rhythm monitor (activity watch).\n\nIn Phase 2, participants in Groups 1 and 2 may continue using the blanket or revert to their usual bedding. At the end of Phase 2 (T4, week 12), follow-up questionnaires will assess sleep and user experience, including satisfaction, perceived benefits, barriers, and drawbacks of the blanket. Group 3 will then be offered a special blanket for an 8-week trial.\n\nParticipants The investigators aim to recruit 672 young people aged 16-24 with sleep problems.\n\nInclusion criteria are age 16-24 years and sleep problems measured by Insomnia Severity Index (score \\>10). Exclusion criteria are any underlying somatic, psychological, or neurological condition significantly affecting sleep quality; use of medications affecting sleep; pregnancy; shift work or night work; previous use of special blankets for sleep improvement and insufficient Danish language skills (questionnaires in Danish).\n\nSignificance and Relevance\n\nThe investigators anticipate that the findings will contribute to the current understanding of the non-pharmacological management of sleep problems, related mental and physical health outcomes, and underlying stress-related mechanisms of special blanket interventions. The results will be relevant to health professionals working with sleep problems, but also to adolescents and younger adults with sleep problems and their parents. New clinical guidelines on sleep problems in children and adolescents recommend non-pharmacological treatments as the first choice, specifically mentioning the potential efficacy of special blankets. The proposed project will help inform further development of such guidelines and related clinical practice. If special blankets are found to be effective in reducing insomnia, they could serve as an inexpensive, easily disseminated, and administered treatment with no known side effects, with the potential to greatly reduce the personal, as well as societal costs of insomnia.",[28,192],"Insomnia",[194,135,195,196,164,197,198,199,200,201,202,203],"insomnia","RCT","blankets","sleep problems","sleep quality","young adults","sleep interventions","sleep disturbances","saliva","adolescents","2025-12-09",{"date":206,"type":40},"2025-12-17",{"date":208,"type":40},"2025-10-15",{"date":210,"type":22},"2027-02-01",{"name":212,"class":47},"Aarhus University Hospital",{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":18,"minAge":220,"maxAge":221,"enrollmentInfo":222,"targetDuration":4,"studyType":23,"phases":224,"briefSummary":225,"conditions":226,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":234,"locationsCount":116},"100583677","preoperative-sleep-intervention-on-postoperative-delirium-in-school-aged-children-undergoing-congenital-heart-surgery-100583677","NCT06879431","Preoperative Sleep Intervention on Postoperative Delirium in School-aged Children Undergoing Congenital Heart Surgery","The Impact of Cognitive Behavioral Intervention On Postoperative Delirium In School-aged Children With Sleep Disorder Undergoing Congenital Heart Surgery: A Multicenter, Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n1. Age 0-36 months\n2. Scheduled to undergo elective corrective surgery for congenital heart disease under cardiopulmonary bypass.\n3. Sleep disorder assessed by Children's Sleep Habits Questionnaire (CSHQ) (CSHQ score \\>48)\n\nExclusion Criteria:\n\n1. Preoperative use of sleep therapy-related medications\n2. The risk adjustment in congenital heart surgery-1 (RACHS-1 classification) ≥4\n3. History of preoperative cardiac assist device, mechanical ventilation support, or asphyxia rescue\n4. Emergency surgery or preoperative ICU admission\n5. History of neurodevelopmental disorders such as autism spectrum disorder, attention deficit hyperactivity disorder, or psychiatric disorders such as depression\n6. Combined severe hepatic and renal dysfunction\n7. Combination of non-cardiac malformations (adenoid hypertrophy, tracheobronchial stenosis, polysplenism, anaplastic syndrome, Down syndrome, DiGeoge syndrome, diabetes mellitus, reproductive system abnormalities, anal atresia and Williams syndrome, eye disorders)\n8. History of preoperative cerebral ischemia and hypoxia\n9. Concurrent participation in other clinical trials\n10. Refusal of the family to sign the informed consent form or poor compliance by the child","6 Years","12 Years",{"count":223,"type":22},544,[25],"This is a multicenter, randomized, controlled clinical trial aimed to determine whether preoperative sleep interventions could reduce the incidence of adverse outcomes, such as postoperative delirium, in sleep-disordered school-aged children undergoing congenital heart surgery. The study will include infants and toddlers undergoing elective cardiac surgery with sleep disorders, assessed by the Children's Sleep Habits Questionnaire (CSHQ). All participants will be randomly assigned to the intervention group and Controll group in a 1:1 ratio. The intervention group received a short intensive cognitive-behavioral intervention 7-14 days before surgery, and no intervention was imposed on the control group. The results of this study will provide suggestions for the prevention of delirium after cardiac surgery.",[107,28,227],"Congenital Heart Disease (CHD)","2025-05-27",{"date":230,"type":40},"2025-05-31",{"date":232,"type":40},"2025-04-28",{"date":92,"type":22},{"name":115,"class":47},{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":18,"minAge":242,"maxAge":243,"enrollmentInfo":244,"targetDuration":4,"studyType":23,"phases":246,"briefSummary":247,"conditions":248,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":255,"locationsCount":116},"100582337","preoperative-sleep-intervention-on-postoperative-delirium-in-infants-and-toddlers-undergoing-congenital-heart-surgery-100582337","NCT06861998","Preoperative Sleep Intervention on Postoperative Delirium in Infants and Toddlers Undergoing Congenital Heart Surgery","The Impact of Behavioral Intervention On Postoperative Delirium In Sleep-Disordered Infants and Toddlers Undergoing Congenital Heart Surgery: A Multicenter, Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n1. Age 0-3 years\n2. Scheduled to undergo elective corrective surgery for congenital heart disease under cardiopulmonary bypass.\n3. Children with sleep disorders who are screened by the Brief Infant Sleep Questionnaire-Revised short form (BISQ-R SF).\n\nExclusion Criteria:\n\n1. Infants and toddlers who have taken any relevant preoperative treatment for sleep problems\n2. The risk adjustment in congenital heart surgery-1 (RACHS-1 classification) ≥4.\n3. Preoperative history of cerebral ischemia and hypoxia, developmental disorders such as autism spectrum disorders, etc.\n4. Presence of any other preoperative acute or chronic medical condition (mechanical ventilation support, history of asphyxia rescue, severe hepatic or renal dysfunction, or comorbidities with other non-cardiac malformations)\n5. Concurrent participation in other clinical trials\n6. Refusal of the family to sign the informed consent or poor compliance of the child.","1 Day","3 Years",{"count":245,"type":22},452,[25],"This is a multicenter, randomized, controlled clinical trial aimed to determine whether preoperative sleep interventions could reduce the incidence of adverse outcomes, such as postoperative delirium, in sleep-disordered infants and toddlers undergoing congenital heart surgery. The study will include infants and toddlers undergoing elective cardiac surgery with sleep disorders, assessed by the Brief Infant Sleep Questionnaire (BISQ). All participants will be randomly assigned to the intervention group and Controll group in a 1:1 ratio. The intervention group received sleep hygiene education and a bedtime routine based on touch, the control group received only sleep hygiene education. The primary outcome is the incidence of postoperative delirium within 7 days after surgery or before discharge, and secondary outcomes include postoperative sleep quality, pain score, perioperative organ injury (including AKI, acute lung injury, and postoperative liver dysfunction), clinical recovery and prognosis. The results of this study will provide suggestions for the prevention of delirium after cardiac surgery.",[107,28,227],"2025-05-24",{"date":251,"type":40},"2025-05-28",{"date":253,"type":40},"2025-04-30",{"date":92,"type":22},{"name":115,"class":47},{"id":257,"slug":258,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":262,"eligibilityCriteria":263,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":264,"enrollmentInfo":265,"targetDuration":4,"studyType":23,"phases":267,"briefSummary":268,"conditions":269,"keywords":271,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":116},"100580860","impact-of-weighted-blankets-on-sleep-quality-100580860","NCT06842797","Impact of Weighted Blankets on Sleep Quality","The Effect of Various Types of Weighted Blankets on Sleep Quality and Quantity: A Randomized Cross-Over Controlled Study","CosyNight","Inclusion Criteria:\n\n* Healthy individual\n\nExclusion Criteria:\n\n* history of mental illness\n* history of epilepsy\n* any acute or chronic condition that would limit the ability of the patient to participate in the study","45 Years",{"count":266,"type":22},20,[25],"Weighted blankets have been used to improve sleep quality in children with neurodevelopmental disorders. It is not known, however, whether weighted blankets can improve overnight sleep in healthy adults and those with poor sleep quality and what is the optimal weight of those blankets for achieving the best results.\n\nAIMS: The purpose of the present study is to investigate the effect of 4 different weights of weighted blankets on sleep in participants with low sleep quality.",[28,270],"Sleep",[272,194,273,274,275],"weighted blankets","poor sleep","fatigue","alternative medicine","2025-03-19",{"date":278,"type":40},"2025-03-24",{"date":280,"type":40},"2025-02-20",{"date":282,"type":22},"2025-09-15",{"name":284,"class":47},"University of Thessaly",{"id":286,"slug":287,"hasResults":11,"nctId":288,"briefTitle":289,"officialTitle":289,"acronym":4,"eligibilityCriteria":290,"healthyVolunteers":11,"sex":18,"minAge":220,"maxAge":78,"enrollmentInfo":291,"targetDuration":4,"studyType":23,"phases":293,"briefSummary":294,"conditions":295,"keywords":297,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":116},"100578217","intervention-with-weighted-blankets-for-children-with-adhd-and-sleep-problems-implementation-and-effectiveness-100578217","NCT06808425","Intervention With Weighted Blankets for Children With ADHD and Sleep Problems: Implementation and Effectiveness","Inclusion Criteria:\n\n* Children diagnosed with ADHD (DSM-5) and sleep problems (defined by screening instrument).\n* Being a patient at child and adolescent mental health service (CAMHS) in Region Halland, Sweden.",{"count":292,"type":22},200,[25],"The aim is to study a sleep intervention with weighted blankets in children with ADHD and sleep problems regarding 1) short- and long-term effects on sleep and health-related outcomes in comparison with standard treatment (melatonin), 2) barriers and facilitators to implementation in routine clinical practice, and 3) health-economic outcomes.",[132,296,270,28],"Sleep Disturbances",[298,299,272,300,197],"implementation","sleep intervention","children with ADHD","2025-03-12",{"date":303,"type":40},"2025-03-14",{"date":305,"type":40},"2025-02-03",{"date":307,"type":22},"2034-02",{"name":309,"class":47},"Halmstad University",{"id":311,"slug":312,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":314,"acronym":315,"eligibilityCriteria":316,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":317,"targetDuration":4,"studyType":23,"phases":319,"briefSummary":320,"conditions":321,"keywords":330,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":70},"100576742","co-occurence-of-mental-illness-and-problematic-alcohol-use-an-internet-based-cognitive-behavior-therapy-intervention-100576742","NCT06789250","Co-occurence of Mental Illness and Problematic Alcohol Use: an Internet-based Cognitive Behavior Therapy Intervention","CoMiT","Inclusion Criteria:\n\n* Age ≥18 years\n* AUDIT ≥ 6 points for women and ≥ 8 points for men\n* Symptoms of depression, anxiety disorder and\u002For stress-related illness\n* Adequate ability to speak, read and write Swedish\n* Having access to the internet and a smartphone, computer or other device.\n\nExclusion Criteria:\n\n* Ongoing psychological treatment.\n* Ongoing medication for AUD\n* Recent changes (within the past three months) in psychiatric medication or planned changes during the treatment period. New medication prescribed during the study shall be reported but will not lead to exclusion\n* Severe psychiatric disorders based on a Mini-International Neuropsychiatric Interview (MINI) interview and reported medical history\n* Severe medical conditions that may impede participation in the study\n* Severe cognitive impairment\n* Current suicidality\n* Severe alcohol addiction where specialized treatment is more appropriate\n* Risk for severe alcohol withdrawal symptoms with a need for medical treatment. Participation is possible after completing alcohol withdrawal treatment within the ordinary health-care system, accessible to the Swedish population.\n* Substance use disorder, other than alcohol or nicotine, within the past six months.",{"count":318,"type":22},240,[25],"The goal of this clinical trial is to learn if internet-based cognitive behavior therapy (ICBT ) works to treat co-occurent of problematic alcohol use and mental illness including mild to moderate symptoms of either depression, anxiety, stress or disturbed sleep.\n\nThe main questions the study aims to answer are:\n\n* Does the ICBT program lower the self-rated suffering from mental illness?\n* Does the ICBT program lower the self-reported alcohol intake? Researchers will compare the ICBT program to the participants who are rancomized to a control grout that receives weekly attention from the research team, to see if the treatment works. In both groups, the participants will have the opportunity to ask for support from a therapist during the week days.\n\nParticipants are adults living in Sweden. They will:\n\n* Receive an ICBT program supported by a trained therapist. It consists of modules that the participants will work with on their computer for 10 weeks. Some modules will be compulsory and other optional for the participants.\n* Fill out forms to rate their mental illness and alcohol intake at the start and the end of the study as well as once every week during treatment.\n\nPrimary outcome measures are depression, anxiety and stress symptoms (measured with Depression Anxiety and Stress Scale 21 (DASS-21)) and alcohol intake measured with self-reported amounts. Other, secondary, outcome measures used will for example be about insomnia symptoms and disability assessment. Pre-treatment measurement, post-treatment measurement and 6-months and 12-months follow up is planned to be collected through an online survey.",[322,323,324,325,326,327,28,328,329],"Alcohol Drinking Related Problems","Alcohol Use Disorders","Depressive Disorders","Mental Illness","Mental Stress","Mental and Behavioral Disorders","Stress Disorders","Anxiety Disorder\u002FAnxiety State",[331,332,333,334,335,336,337,338,339,340,341],"Internet intervention","Depression","Anxiety","Individually tailored","Transdiagnostic","Internet-based cognitive behavioral therapy (ICBT)","Stress","Sleeping disorders","Mental illness","Harmful alcohol use","Alcohol addiction","2025-02-21",{"date":344,"type":40},"2025-02-24",{"date":346,"type":40},"2025-01-05",{"date":348,"type":22},"2026-05",{"name":350,"class":351},"Linkoeping University","OTHER_GOV",{"id":353,"slug":354,"hasResults":11,"nctId":355,"briefTitle":356,"officialTitle":356,"acronym":357,"eligibilityCriteria":358,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":359,"targetDuration":4,"studyType":23,"phases":361,"briefSummary":362,"conditions":363,"keywords":364,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":116},"100575123","whatsapp-based-psycho-socio-educational-intervention-welove-for-prevention-of-psychological-and-sleep-problems-in-pregnant-women-and-their-partners-a-three-arm-double-blinded-pilot-randomised-controlled-trial-100575123","NCT06768190","WhatsApp-based Psycho-socio-educational Intervention (WeLove) for Prevention of Psychological and Sleep Problems in Pregnant Women and Their Partners: A Three-arm Double-blinded Pilot Randomised Controlled Trial","WhatsApp-based","Inclusion Criteria:\n\n* pregnant with a gestation of \\>12 to 28 weeks and their partners over 18 years\n* able to read and understand Chinese\n* have electronic devices with WhatsApp that can contact the Internet\n* can provide written consent and voluntary participation in this study\n\nExclusion Criteria:\n\n* current severe medical illnesses\n* psychological and sleep disorders",{"count":360,"type":22},120,[25],"Objectives: (1) evaluate the feasibility and acceptability of the WhatsApp-based psycho-socio-educational intervention (WeLove); (2) preliminarily examine the effects of the intervention on psychological symptoms (depression, anxiety, stress symptoms), sleep quality, and life satisfaction; and (3) preliminarily examine the interdependence between psychological symptoms and sleep quality in pregnant women and their partners.\n\nMethods: The investigators will use WhatsApp to provide the six sessions of the intervention, which include psychological, social, and educational components. A three-arm double-blinded pilot randomised controlled trial (RCT) is used in 60 couples, followed by individual face-to-face interviews for process evaluation in 10 to 20 couples based on data saturation. Participants will be assigned to one of three groups and 20 couples per group: intervention 1 (couples for WeLove), intervention 2 (pregnant women for WeLove), or the control group (use WhatsApp as normal). Participants will be assessed pre- and post-intervention. Generalised estimating equation analysis and thematic analysis will be performed to examine the research objectives.",[28,29,30],[32,33,34,35],"2025-01-21",{"date":367,"type":40},"2025-01-23",{"date":369,"type":40},"2025-01-06",{"date":371,"type":22},"2027-01-31",{"name":46,"class":47},{"id":374,"slug":375,"hasResults":11,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":4,"eligibilityCriteria":379,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":380,"targetDuration":4,"studyType":23,"phases":382,"briefSummary":383,"conditions":384,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":393,"locationsCount":4},"100575827","effect-of-preoperative-sleep-intervention-on-postoperative-delirium-in-adult-patients-undergoing-cardiac-surgery-100575827","NCT06777342","Effect of Preoperative Sleep Intervention on Postoperative Delirium in Adult Patients Undergoing Cardiac Surgery","Effect of Preoperative Sleep Intervention on Postoperative Delirium in Adult Patients Undergoing Cardiac Surgery: a Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Scheduled for elective coronary artery bypass grafting and\u002For valve surgery.\n3. Preoperative Pittsburgh Sleep Quality Index (PSQI) score ≥ 5.\n\nExclusion Criteria:\n\n1. History of neurosurgery, cerebral hemorrhage, cerebral infarction, delirium, dementia, or other neurological diseases.\n2. History of mental illness.\n3. Habitual heavy drinking.\n4. American Society of Anesthesiologists (ASA) grade IV or above.\n5. Severe hepatic dysfunction (Child-Pugh Grade C) or renal dysfunction (chronic kidney disease stages 3-4).\n6. Contraindications to melatonin use, such as allergies to melatonin-related ingredients.\n7. Currently taking melatonin, melatonin receptor agonists, sleep-related medications, sedatives, antipsychotic medications, or opioids.\n8. Inability to communicate due to hearing or speech impairment, or refusal to provide informed consent.",{"count":381,"type":22},1281,[25],"This is a multicenter, randomized, controlled clinical trial aimed to determine whether preoperative sleep interventions could reduce the incidence of adverse outcomes, such as postoperative delirium, in adult patients undergoing cardiac surgery. The study will include adult patients undergoing coronary artery bypass grafting and\u002For valve surgery with concomitant sleep disorders, as assessed by the Pittsburgh Sleep Quality Index. All participants will be randomly assigned to placebo, placebo + cognitive behavioral therapy, and melatonin + cognitive behavioral therapy in a 1:1:1 ratio. The primary outcome is the incidence of postoperative delirium within 7 days after surgery or before discharge, and secondary outcomes include postoperative cognitive function, sleep quality, and severity and duration of delirium. The results of this study will provide suggestions for the prevention of delirium after cardiac surgery.",[107,28,385,386],"CABG","Valve Surgery","2025-01-10",{"date":389,"type":40},"2025-01-15",{"date":391,"type":22},"2025-02-01",{"date":92,"type":22},{"name":115,"class":47},{"id":395,"slug":396,"hasResults":11,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":4,"eligibilityCriteria":400,"healthyVolunteers":11,"sex":18,"minAge":401,"maxAge":78,"enrollmentInfo":402,"targetDuration":404,"studyType":104,"phases":4,"briefSummary":405,"conditions":406,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":4},"100568847","preoperative-sleep-disorders-and-postoperative-delirium-in-children-undergoing-congenital-heart-surgery-100568847","NCT06686550","Preoperative Sleep Disorders and Postoperative Delirium in Children Undergoing Congenital Heart Surgery","The Impact of Preoperative Sleep Disorders on the Incidence of Postoperative Delirium in Children Undergoing Congenital Heart Surgery: A Prospective, Observational, Cohort Study","Inclusion Criteria:\n\n* Aged more than 28 days and less than 14 years old；\n* Scheduled to undergo elective corrective surgery for congenital heart disease under cardiopulmonary bypass.\n\nExclusion Criteria:\n\n* Emergency surgery;\n* Combined with severe hepatic and renal dysfunction (with a diagnosis of acute or chronic renal insufficiency or requiring renal replacement therapy; with a diagnosis of acute or chronic hepatic insufficiency or requiring artificial liver treatment);\n* Combined with non-cardiac malformations (adenoidal hypertrophy, tracheobronchial stenosis and ocular disorders);\n* History of preoperative cerebral ischemia or haemorrhage;\n* Refuse to sign the informed consent form or the child has poor compliance.","28 Days",{"count":403,"type":22},435,"1 Year","The investigators are going to conduct a prospective observational cohort study in pediatric patients aged 28 days to 14 years old scheduled for elective cardiac surgery with cardiopulmonary bypass. The primary purpose of this study is to explore the effect of preoperative sleep disturbance on the incidence of postoperative delirium. Sleep status will be assessed using the Brief Infant Sleep Questionnaire(BISQ) and Children's Sleep Habits Questionnaire (CSHQ), and postoperative delirium status will be evaluated by Cornell assessment of pediatric delirium(CAPD). During the peri-operative period, children will wear actigraphs to record their sleep parameters.",[107,28,227],"2024-11-11",{"date":409,"type":40},"2024-11-13",{"date":411,"type":22},"2024-11-10",{"date":413,"type":22},"2026-06-15",{"name":115,"class":47}]