[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-insomnia-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-insomnia-disorder":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,44,79,106,133],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100630377","comparing-acoustic-resonance-therapy-art-vs-cognitive-behavioral-therapy-for-insomnia-cbt-i-100630377",false,"NCT07486882","Comparing Acoustic Resonance Therapy (ART) vs. Cognitive Behavioral Therapy for Insomnia (CBT-I)","A Feasibility Pilot Comparing Acoustic Resonance Therapy (ART) to Cognitive Behavioral Therapy for Insomnia (CBT-I) for Treating Patients With Moderate to Severe Chronic Insomnia Disorder","Inclusion Criteria:\n\n* Adult subjects, 22 years of age and older at screening\n* Moderate-to-severe insomnia disorder, as defined by the International Classification of Sleep Disorders (ICSD-3)\\* and the Insomnia Severity Index (ISI) and have been diagnosed for more than three months.\n* Not pregnant by subject self-report at time of consent.\n* Have the ability to provide informed consent.\n* Have the ability to complete all aspects of this trial.\n* Have access to an iOS mobile device (iPhone X or above).\n* Have no contraindicating comorbid health condition that would interfere with the proper use of the SONU Headband system, as determined by the clinical investigators.\n* Participants who are taking sleep-aiding pills must agree to no changes to medication and dosage during the study.\n\n  * According to the third edition of the International Classification of Sleep Disorders (ICSD-3), insomnia is characterized by difficulty in either initiating sleep, maintaining sleep continuity, or poor sleep quality\n\nExclusion Criteria:\n\n* Patients who are unable to commit to avoiding the consumption of alcohol during the study.\n* Patients who are unable to commit to avoid consumption of caffeine after 12 pm (noon).\n* Patients who have a clinically significant or unstable medical or surgical condition.\n* Participants using pacemakers or cardiac monitors.\n* Participants with severe physical illness or immediately post-surgery\n* Participants with severe mental disorders, such as schizophrenia, severe major depression, severe anxiety, bipolar disorder, dementia, substance use disorder, or severe neurological diseases such as a seizure, stroke, or Parkinson's disease.\n* Participants with other serious sleep disorders, such as severe obstructive sleep apnea.\n* Participants who are unable to attend regular follow-up evaluations.\n* Any unstable medical or mental health condition as determined by the physician investigator.","ALL","22 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"NA","The purpose of this study is to compare changes in sleep quality in patients with moderate to severe insomnia, in participants randomized to Cognitive Behavioral Therapy for Insomnia (CBT-I) arm versus those randomized to the SONU Headband Acoustic Resonance Therapy (ART) arm at end of treatment (6 weeks).",[26],"Chronic Insomnia Disorder",[28,29,30],"insomnia","cognitive behavioral therapy","acoustic resonance therapy","RECRUITING","2026-07-16",{"date":34,"type":35},"2026-07-20","ACTUAL",{"date":37,"type":35},"2026-03-17",{"date":39,"type":20},"2027-07-31",{"name":41,"class":42},"Mayo Clinic","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":43},"100634674","phase-4-a-smart-approach-to-evaluating-the-benefits-of-common-prescription-and-otc-medications-for-insomnia-100634674","NCT07542756","A SMART Approach to Evaluating the Benefits of Common Prescription and OTC Medications for Insomnia","Sequential Multiple Assignment Randomized Trial Comparing Commonly Prescribed and Over the Counter Medications for the Treatment of Insomnia in Adults","Inclusion Criteria\n\n* Adults aged 18-80 years.\n* Meet DSM-5 criteria for Insomnia Disorder.\n* Score ≥15 on the Insomnia Severity Index (ISI).\n* Sleep initiation and\u002For maintenance complaints: ≥30 minutes in duration, occurring ≥3 nights\u002Fweek, with a duration of ≥3 months.\n* Willingness to discontinue use of all sleep-related medications prior to enrollment.\n* Completion of a 2-week washout period before starting any study medication.\n* Willingness to provide clinician assent for participation.\n\nExclusion Criteria\n\nPatients will be ineligible if they meet any of the following criteria: self-reported daytime napping (≥1 hour per day on ≥3 days per week); a history of suicidal attempts or current ideation, acute or chronic psychiatric or medical condition not controlled by therapy (according to their primary care physician), or current alcohol or drug misuse; or the diagnoses of (or high risk for) other sleep disorders, including circadian rhythm disorders (phase advance or phase delay syndromes), shift work related sleep disorder (\"day sleepers\" who work \\~11pm to 7am) and those with rotating shiftwork schedules. To determine eligibility, all subjects will be screened using a multitier process including: an online screener; an intake interview; a review of the subjects EMR; and, finally, the receipt of the patient's PCP's assent. The following provides additional listing and details (AD) for the Exclusion Criteria:\n\nGeneral Considerations\n\n* Age \\\u003C 18 or \\> 80 years old\n* Inadequate English language comprehension\n* Minimal facility with smartphones, computers, i-Pads, or the internet.\n\nWomen's Health Given the potential for teratogenic effects with at least trazodone (FDA Class C), women intending to become pregnant, or who are pregnant, or who are breastfeeding will not be eligible for the study. Women will be asked to confirm the use of birth control using self-report and, if applicable, by providing evidence of contraceptive medication (e.g., prescription or pill pack). We will perform a urine pregnancy test at baseline for female participants who are of reproductive age to confirm eligibility. At study enrollment, participants will be told to alert the study team and stop taking study medications if they become pregnant. Participants will be asked to test for pregnancy in the event of a missed cycle.\n\nMedical and Psychiatric Considerations\n\n* Acute or unstable psychiatric conditions\n* Unstable medical condition, significant medical disorder, or acute illness (as determined by their PCP), within one month prior to the study period.\n* Significant liver or kidney problems\n* Pheochromocytoma or porphyria (contraindicated for trazodone)\n* Epilepsy or Seizure Disorder (contraindicated for trazodone)\n* Glaucoma or urinary retention (contraindicated for doxepin)\n* Increased ocular pressure (contraindicated for diphenhydramine)\n* Diagnosis of alcohol or substance use disorder within 2 years prior to the screening visit\n* Inability to refrain from drinking alcohol or substance use for at least 3 consecutive days\n\nSleep Disorders and Sleep Habits\n\n* Any lifetime history of (diagnosis of) breathing disorders, including COPD and sleep apnea.\n* Shift work related sleep disorder (work \\~11pm to 7am and \"day sleeper\") and rotating shiftwork schedules\n* Circadian rhythm disorders (phase advance or phase delay syndromes)\n* Self-reported usual daytime napping ≥1 hour per day (3 or more days per week)\n\nMedications and Concomitant meds\n\n* Known hypersensitivity or contraindication to study drugs\n* Known hypersensitivity or contraindication to drugs of the same class as the study treatments\n* Known hypersensitivity or contraindication to any excipients of the study drug formulation\n* Treatment with CNS active drugs prohibited by the protocol for five half-lives of the respective drug (or 2 weeks)\n\nLifestyle\n\n* Heavy tobacco use (≥1 pack of cigarettes a day or inability to refrain from smoking during the night)\n* Not able or willing to stop treatment with moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors","18 Years","80 Years",{"count":54,"type":20},1200,[56],"PHASE4","The purpose of this study is to assess the relative effectiveness, safety, and durability of the most commonly used prescription (zolpidem, trazodone) and over-the-counter (OTC) (melatonin, diphenhydramine) medications for insomnia, as well as a less commonly used prescription that may have a better risk\u002Fbenefit profile (doxepin).",[59,60,61,26],"Insomnia","Insomnia Disorder","Chronic Insomnia",[63,59,64,65,66,67,68,69],"Sleep","Zolpidem","Diphenhydramine","Doxepin","Melatonin","Trazodone","Placebo","2026-06-04",{"date":72,"type":35},"2026-06-05",{"date":74,"type":35},"2026-05-01",{"date":76,"type":20},"2032-01-01",{"name":78,"class":42},"University of Pennsylvania",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":43},"100571991","translation-and-validation-of-the-french-version-of-the-sleep-regularity-questionnaire-a-new-tool-to-address-the-the-challenge-of-sleep-health-100571991","NCT06727448","Translation and Validation of the French Version of the Sleep Regularity Questionnaire: a New Tool to Address the the Challenge of Sleep Health","PRIMO","Inclusion Criteria:\n\n* Patient ≥ 18 years of age\n* Patient with indication for 14-day actimetry for chronic insomnia or circadian rhythm disorder\n* Patients with an indication for 14-day actimetry to assess sleep-wake rhythms, for example prior to a 36-hour polysomnographic recording to diagnose central hypersomnia (narcolepsy or idiopathic hypersomnia).\n* Patient affiliated to or benefiting from a social security scheme\n* Patient with French as mother tongue, able to read and write French.\n* Patient able to understand and complete questionnaires independently\n* Patient informed and not opposed to participating in the study\n\nExclusion Criteria:\n\n* Current psychiatric disorder (mood disorders, anxiety, psychosis, sleep-interfering use disorder) assessed during interview with investigator\n* Current neurological disorder affecting sleep (neurodegenerative disease, stroke, epilepsy) assessed during interview with investigator\n* Unstable cardiovascular or respiratory diseases\n* Pregnant or breast-feeding women\n* Adults under guardianship or curatorship\n* Opposition to participation expressed by healthy patient\u002Fvolunteer",{"count":87,"type":20},50,"OBSERVATIONAL","Sleep is an essential function for physical and mental health. The mismatch between biological rhythms and the social rhythms of individuals is increasingly common in modern societies. This sleep irregularity can have numerous consequences on mental health, cardiometabolic health, the immune system, functioning, and quality of life. To address the public health issue of sleep irregularity, it is important to be able to obtain a valid and reliable measure. The Sleep Regularity Questionnaire (SRQ) by Dzierzewski et al. addresses this issue, but has never been translated into French. The aim of the study is to translate and validate the French version of the Sleep Regularity Questionnaire.",[26,91],"Circadian Rhythm Disorders",[93,94,95,96],"circadian rhythm disorder","Sleep Regularity Questionnaire","SRQ","chronic insomnia disorder","2025-12-09",{"date":99,"type":35},"2025-12-10",{"date":101,"type":35},"2024-12-23",{"date":103,"type":20},"2026-06-23",{"name":105,"class":42},"University Hospital, Bordeaux",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":21,"phases":115,"briefSummary":116,"conditions":117,"keywords":120,"overallStatus":123,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":4},"100572027","a-randomized-single-blind-study-evaluating-the-efficacy-and-cost-effectiveness-of-brief-behavioral-therapy-for-chronic-insomnia-patients-under-medication-treatment-at-nguyen-trai-hospital-ho-chi-minh-city-100572027","NCT06727916","A Randomized, Single-Blind Study Evaluating the Efficacy and Cost-Effectiveness of Brief Behavioral Therapy for Chronic Insomnia Patients Under Medication Treatment At Nguyen Trai Hospital, Ho Chi Minh City","Evaluation of Efficacy and Cost-effectiveness of Brief Behavioral Therapy for Chronic Insomnia Patients Under Medication Treatment At Nguyen Trai Hospital, Ho Chi Minh City","Inclusion Criteria:\n\nThe study includes patients who fully meet the following criteria:\n\nPatients with an outpatient prescription diagnosed with \"sleep disorder\" (ICD-10: G47), insomnia disorder \\[difficulty initiating and maintaining sleep\\] (ICD-10: G47.0), nonorganic insomnia (ICD-10: F51.0), or agrypnia \\[sleep disorder\\] (ICD-10: U55.621). Diagnoses are based on DSM-5 criteria.\n\nPatients aged 18 years or older. Agreement to participate in the study.\n\nExclusion Criteria:\n\nCognitive impairment (inability to understand counseling content). Presence of a triggering factor during the study period (hospitalization, acute exacerbation of comorbid conditions, or a psychological trauma) as these conditions may induce insomnia.\n\nConditions incompatible with sleep restriction therapy:\n\nEpilepsy. Untreated obstructive sleep apnea (diagnosed or high-risk based on STOP-BANG screening).\n\nUntreated bipolar disorder. Suicidal intent. Parasomnias related to NREM sleep (sleepwalking, night terrors). Diagnosed with other sleep disorders.",{"count":114,"type":20},100,[23],"Insomnia disorder is considered quite common and is recognized as a risk factor for psychiatric disorders. In industrialized countries, chronic insomnia disorder is estimated to affect about 5-10% of the population, with some studies indicating that this rate can reach up to 33% among adults. Research in the Netherlands has shown that insomnia symptoms increase the risk of developing, relapsing, and prolonging mood disorders in men and are associated with recurrent anxiety disorders in women. Without treatment, insomnia disorders are challenging to improve and can impact patients' economic stability and health. Treating insomnia can support recovery and prevent mental disorders, particularly mood disorders.\n\nOne of the commonly referenced non-pharmacological treatments for insomnia worldwide is Cognitive Behavioral Therapy for Insomnia (CBT-I). This therapy has been recognized by the American College of Physicians as a first-line and highly effective treatment for insomnia. However, it still faces several barriers to widespread application in clinical practice, such as resource constraints and the time commitment required from patients. As a result, some studies abroad have shown that physicians may be reluctant to recommend CBT-I alone, even though it is considered the preferred treatment. To address these challenges, numerous international studies have expanded the range of providers (such as pharmacists and nurses) or adopted shortened versions, such as Brief Behavioral Treatment for Insomnia (BBT-I), in hospitals or community pharmacies. BBT-I has been proven effective among older adults with a 2+2 design (two in-person sessions and two follow-up calls) and among younger adults using an electronic format. This is a brief, evidence-based therapy designed to encourage the application of CBT-I techniques in primary healthcare settings, demonstrating effectiveness when performed by healthcare providers with basic training. A significant advantage of combining CBT-I and BBT-I in treating insomnia is the reduction in medication use. When effectively implemented, it can shorten treatment duration, reduce hospitalization rates, decrease adverse effects from drug interactions, and improve patients' quality of life, ultimately reducing the financial burden on healthcare facilities and improving the quality of medical services.\n\nIn Vietnam, CBT-I and BBT-I therapies are not yet widely applied or popularized. Based on the current situation and the desire to apply these therapies in treating chronic insomnia patients to improve quality of life and reduce medication costs, in 2023, Nguyen Trai Hospital collaborated with Thong Nhat Hospital and the Saigon Center for Pharmaceutical Science and Technology to conduct a city-level scientific and technological research program on the application of BBT-I in supporting the treatment of chronic insomnia in the elderly. The research developed a \"Sleep Support Guide\" as a resource for healthcare workers to counsel patients and provide essential information related to insomnia. Results from the study also showed that BBT-I could help improve sleep-related parameters, life quality, and sleep quality among elderly patients. However, the study had some limitations, such as being conducted only on elderly subjects, with a follow-up period of one month post-intervention for sleep parameters and three months for medication usage metrics, without a cost-effectiveness comparison with medication-only treatments. Therefore, further in-depth research with a wider range of subjects and a comparison with standard hospital treatments is necessary for broader application of this method in practice.\n\nObjective 1: To investigate the characteristics of chronic insomnia patients receiving medication at Nguyen Trai Hospital in Ho Chi Minh City.\n\nObjective 2: To assess the effectiveness of BBT-I in improving sleep quality and quality of life after one and three months compared to non-application in chronic insomnia patients receiving medication at Nguyen Trai Hospital in Ho Chi Minh City.\n\nObjective 3: To evaluate the cost-effectiveness of BBT-I in improving sleep quality and quality of life when applied to chronic insomnia patients receiving medication at Nguyen Trai Hospital in Ho Chi Minh City.",[26,61,118,119],"BBT-I","CBT-I",[121,122,118,119],"Chronic insomnia disorder","chronic insomnia","NOT_YET_RECRUITING","2024-12-06",{"date":126,"type":35},"2024-12-11",{"date":128,"type":20},"2024-12-15",{"date":130,"type":20},"2027-09-30",{"name":132,"class":42},"Nguyen Trai Hospital",{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":21,"phases":142,"briefSummary":143,"conditions":144,"keywords":145,"overallStatus":123,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":43},"100562728","fmt-for-insomnia-disorder-fmt-sleep-100562728","NCT06606938","FMT for Insomnia Disorder (FMT-SLEEP)","Faecal Microbiota Transplantation for Insomnia Disorder: a Randomized, Double-blind, Placebo-controlled Trial","Inclusion Criteria:\n\n* 1\\. Individuals aged 18 and above\n* 2\\. Subjects who were diagnosed with chronic insomnia disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and with moderate or above insomnia disorder defined as ISI \\> 14\n\nExclusion Criteria:\n\n* 1\\. Having an additional sleep disorder, such as restless legs syndrome, or circadian rhythm sleep disorder, that can significantly disrupt the sleep cycle as ascertained by Diagnostic Interview for Sleep Patterns and Disorders (DISP)\n* 2\\. Requiring immediate psychiatric care (e.g., imminently suicidal subjects) or have attempted suicide in the past 6 months\n* 3\\. Change of treatment or therapy for insomnia within 4 weeks\n* 4\\. Known history of severe organ failure (including decompensated cirrhosis), renal failure on dialysis, suffering from human immunodeficiency virus infection\n* 5\\. Confirmed active malignancy\n* 6\\. Had abdominal surgery\n* 7\\. Contraindications to GI endoscopy\n* 8\\. On shift work\n* 9\\. Taking antibiotics, probiotic or prebiotic preparations within 4 weeks\n* 10\\. Known pregnancy\n* 11\\. Mental retardation or inability to provide informed consent\n* 12\\. Are participating in other interventional studies",{"count":141,"type":20},74,[23],"Insomnia disorder is characterized by difficulty initiating or maintaining sleep, or early morning awakening accompanied by symptoms such as irritability or fatigue during wakefulness. It is one of the most prevalent health concerns in the population and in clinical practice, with more than one-third of adults experience transient insomnia at some point in their lives. In about 40% of cases, insomnia can develop into a more chronic condition. The COVID-19 pandemic has further aggravated sleep problems, with a reported global prevalence of sleep disturbances reaching 40-49%. The implications of insomnia disorder are substantial, encompassing social, economic, psychological, and physical aspects.\n\nBehavioural, cognitive, and pharmacological interventions can all be effective for insomnia. Pharmacological treatment is commonly used but may have drawbacks such as adverse events and inconclusive safety data for certain medications. Many licensed drugs can be effective in the acute treatment of insomnia but are associated with poor tolerability, or information about long-term effects is not available. Alternatively, cognitive behavioural therapy for insomnia (CBT-I), has been recommended as the first-line treatment for chronic insomnia in adults of any age according to the American and European guidelines. But issue of accessibility, compliance\u002Fadherence, and moderate response limit the practicality and applicability of CBT-I.\n\nRecent evidence suggests that the gut microbiota plays a role in regulating sleep behaviour, both directly and indirectly. This has led to the exploration of gut microbiota modulation as a potential therapy for insomnia. Faecal microbiota transplantation (FMT), which is the infusion of faeces from healthy donors to the gut of affected subjects, has shown impressive therapeutic effects for various diseases. Several real-world studies have demonstrated improvements in symptoms of insomnia disorder following FMT. One previous study also indicated the potential of FMT in alleviating post-COVID insomnia. In this randomised, double-blind, placebo-controlled trial, the investigators aim to assess the efficacy of FMT in improving insomnia disorder. Two groups will be recruited in 1:1 ratio. The intervention group will receive FMT while the control group will receive normal saline as placebo. Both groups will have the same assessments.",[26],[146],"Faecal Microbiota Transplantation","2024-09-19",{"date":149,"type":35},"2024-09-23",{"date":151,"type":20},"2024-11-01",{"date":153,"type":20},"2027-04-30",{"name":155,"class":42},"Chinese University of Hong Kong"]