[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"insomnia-comorbid-to-psychiatric-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:insomnia-comorbid-to-psychiatric-disorder":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,55],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100580890","phase-2-lemborexant-for-the-treatment-of-residual-insomnia-in-major-depressive-disorder-mdd-100580890",false,"NCT06843187","Lemborexant for the Treatment of Residual Insomnia in Major Depressive Disorder (MDD)","Lemborexant for the Treatment of Residual Insomnia in Adequately Treated Major Depressive Disorder: A Pilot Randomized Controlled Trial","MDD","Inclusion Criteria:\n\n1. Aged 18 to 70 (inclusive), with a self-reported body mass index (BMI) between 19 and 30 kg\u002Fm2 (inclusive);\n2. Meet criteria for primary MDD diagnosis without psychotic symptoms, as defined by the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5)2, and currently in a MDE, confirmed by the MINI International Neuropsychiatric Interview (MINI)3;\n3. Have not failed more than 2 trials of antidepressant treatments in the current MDE, and have a history of adequate response (clinical outcome rating score of 1 or 2) to at least 1 antidepressant treatment during the current MDE as determined by the Antidepressant Treatment History Form-Short Form (ATHF-SF)4;\n4. Are outpatients;\n5. Did not take non-psychotropic or non-central nervous system (CNS) medications suspected to affect sleep-wake function for at least 4 weeks before starting the study.\n6. Self-reported subjective total sleep time (sTST) ≤ 6.5 hours, subjective sleep onset latency (sSOL) ≥ 30 minutes, and subjective wake after sleep onset (sWASO) ≥ 45 minutes per night. Time spent in bed (either sleeping or attempting to sleep) must be between 7 and 10 hours per night. Self-reported regular bedtime (i.e., the time the participant gets in bed) between 21:00 and 01:00 and regular wake time (i.e., the time the participant wakes and does not go back to sleep) between 05:00 and 10:00;\n7. Confirmation of current insomnia symptoms as determined from responses on the Sleep Diary completed on at least 7 consecutive mornings (minimum 5 of 7 for eligibility), such that sSOL ≥ 30 minutes on at least 3 of the 7 nights and\u002For sWASO ≥ 45 minutes on at least 3 of the 7 nights;\n8. Confirmation of sufficient duration of time spent in bed, as determined from responses on the Sleep Diary on the 7 most recent mornings before the visit, such that there are no more than 2 nights with time spent in bed of duration \\\u003C 7 hours or \\> 10 hours;\n9. Confirmation of regular bedtime (i.e., the time the participant gets in bed) between 21:00 and 01:00 on at least 5 of the 7 preceding nights, and regular wake time (i.e., the time the participant wakes and does not go back to sleep) between 05:00 and 10:00 on at least 5 of the 7 preceding nights.\n10. Have a medically responsible physician (family doctor or psychiatrist) during their enrollment and participation in the trial;\n11. Current 17-Item Hamilton Depression Rating Scale (HAM-D-17)30 score ≥ 8 and reporting an insomnia score of ≥15 on ISI1;\n12. Are able to understand and comply with the requirements of the study, as judged by the investigator(s);\n13. Provide written informed consent before initiation of any study-related procedures;\n14. Own a smartphone and have reliable access to the internet and a browser on which to complete questionnaires.\n\nExclusion criteria:\n\n1. Have taken or participated in any clinical trial of lemborexant and other drugs with the same mechanism (e.g., daridorexant), regardless of treatment outcome;\n2. Have any known sensitivity to lemborexant or their excipients;\n3. A lifetime history (current or previous) of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or psychotic symptoms as determined by the MINI;\n4. Women who are pregnant or lactating (documented by a positive beta-human chorionic gonadotropin \\[beta-hCG\\] or human chorionic gonadotropin \\[hCG\\] urine test with a minimum sensitivity of 25 IU\u002FL or equivalent units of beta-hCG or hCG);\n5. Women who are not using an approved and effective method of contraception or family planning during the study. For example, combined estrogen- and progestogen-containing hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion and ligation, vasectomized partner, sexual abstinence, or two forms of contraception with any barrier method or oral hormones (ie.g., condom plus diaphragm, condom or diaphragm plus spermicide, oral hormonal contraceptives plus spermicide or condom).\n6. Positive toxicology screening results;\n7. If participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions or the therapeutic focus 4 weeks before screening and the entire duration of participation;\n8. Have active suicidal intent as determined by a score of 3 (severe suicidality with a clear plan and\u002For intent) or 4 (very severe: suicidal attempts) on item #3 on the HAM-D-17;\n9. Have had a course of electroconvulsive therapy or intravenous ketamine therapy in the current episode or any previous episode;\n10. Medical history of insomnia associated with another sleep disorder or any condition known to impact sleep. This includes any lifetime diagnosis of sleep-related breathing disorder, periodic limb movement disorder, restless legs syndrome, nightmare disorder, sleep terror disorder, sleepwalking disorder, rapid eye movement (REM) behaviour disorder, narcolepsy, or comorbid nocturia that is causing or exacerbating insomnia;\n11. STOP-Bang5 scores ≥ 5; International Restless Legs Scale (IRLS)6 scores ≥ 16,Epworth Sleepiness Scale (ESS)⁷ ≥ 11\n12. Habitual naps 4 or more days a week, occurring in the late afternoon or evening;\n13. Transmeridian travel across more than 3 time zones in the 2 weeks before screening, or between screening and study baseline, or plans to travel across more than 3 time zones during the study;\n14. Used any modality of treatment for insomnia, including cognitive-behavioural therapy within 2 weeks before screening;\n15. Excessive caffeine use, defined as consuming more than 400 mg of caffeine per day (approximately 4 cups of brewed coffee), or habitual consumption of caffeine after 6:00 p.m., which in the investigator's opinion may contribute to insomnia;\n16. Reports habitually consuming more than 14 drinks containing alcohol per week (females) or more than 21 drinks containing alcohol per week (males);\n17. Used prohibited prescriptions or over-the-counter concomitant medications, or used any medication or sleep aid with known effects on sleep within 2 weeks before screening;\n18. Report a history of sleep-related violent behaviour, or sleep driving, or any other complex sleep-related behaviour (e.g., making phone calls, preparing and eating food);\n19. Diagnosis of substance dependence or abuse within the last 3 months as determined by MINI3;\n20. Have a concomitant major unstable medical illness, cardiac pacemaker, or implanted medication pump;\n21. Have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure except a febrile seizure of infancy, cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis, significant head trauma with loss of consciousness for greater than 5 minutes;\n22. A history of risk factors for Torsade de Pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome) or the use of concomitant medications that prolonged the QTcF interval;\n23. Scheduled for major surgery during the study;\n24. Have a clinical finding that is unstable or that, in the opinion of the investigator(s), would be negatively affected by the study medication or that would affect the study medication (e.g., diabetes mellitus, hypertension, unstable angina);\n25. Have uncorrected hypothyroidism or hyperthyroidism. Subjects needing a thyroid hormone supplement to treat hypothyroidism must have been on a stable dose of the medication for 30 days prior to enrolment;\n26. Have any other condition that, in the opinion of the investigator(s), would adversely affect the subject's ability to complete the study or its measures.\n27. Non-English-speaking individuals because the ability to communicate study information, answer questions accurately and completely about the study, and obtain consent are necessary.","ALL","18 Years","70 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The goal of this clinical trial is to learn if Lemborexant works to treat residual insomnia in adults with depression that is being treated. It will also learn about how practical, tolerable, and effective Lemborexant is. The main questions it aims to answer are:\n\n* Does Lemborexant help participants improve sleep and reduce insomnia symptoms?\n* How practical is it to use Lemborexant (how many participants join, drop out, and follow the study rules)? How do participants feel about using it (based on surveys and interviews)?\n\nResearchers will compare Lemborexant to a placebo (a look-alike substance that contains no drug) to see if Lemborexant works to treat residual insomnia in adequately treated major depressive disorder.\n\nParticipants will:\n\n* Take Lemborexant or a placebo every day for 6 weeks (2 weeks at 5 mg then 4 weeks at 10 mg)\n* Complete clinical assessments and in-person study visits\n* Maintain a digital sleep diary and complete daily and weekly self-report ecological momentary assessments (EMAs)\n* Use a wearable device which will be used to collect and monitor physiological data",[28,29],"Major Depressive Disorder(MDD)","Insomnia Comorbid to Psychiatric Disorder",[31,32,33,34,35,36,37,38,39,40,41],"Lemborexant","Residual Insomnia","Major depressive disorder (MDD)","Ecological momentary assessments (EMA)","Wearable devices","Remote measurement-based care","Randomized controlled trial","Digital health monitoring","Feasibility trial","Pilot study","Placebo-controlled","RECRUITING","2026-05-05",{"date":45,"type":46},"2026-05-08","ACTUAL",{"date":48,"type":46},"2024-09-25",{"date":50,"type":22},"2028-04",{"name":52,"class":53},"Unity Health Toronto","OTHER",1,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":17,"minAge":18,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":23,"phases":66,"briefSummary":68,"conditions":69,"keywords":106,"overallStatus":127,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":54},"100565622","phase-1-evaluating-the-efficacy-and-safety-of-prosomnia-sleep-therapy-in-patients-with-sleep-deprivation-and-chronic-insomnia-100565622","NCT06644573","Evaluating the Efficacy and Safety of PROSOMNIA Sleep Therapy™ in Patients With Sleep Deprivation and Chronic Insomnia","PSHW","By adhering to the following criteria, the study aims to select a population that can safely undergo the PROSOMNIA Sleep therapy and for whom the therapy is most likely to be beneficial, ensuring the reliability and validity of the study outcomes.\n\nINCLUSION CRITERIA:\n\n1. Age Range: 18-65 years of age Reason: This age range includes adults who are most likely to benefit from the PROSOMNIA Sleep therapy and who can provide informed consent. It also excludes children and older adults who may have different physiological responses or additional health risks.\n2. Diagnosed or Undiagnosed Chronic Insomnia:\n\n   Reason: Included subjects have a consistent pattern of sleep disturbances that PROSOMNIA Sleep Therapy aims to treat.\n3. Diagnosed or Undiagnosed Sleep Deprivation:\n\n   Reason: Includes individuals who are not getting enough sleep quantity, which is a key condition that the PROSOMNIA Sleep Therapy aims to address.\n4. Diagnosed or Undiagnosed REM Sleep Inconsistencies:\n\n   Reason: Includes individuals who are not getting enough sleep quality and those with specific REM sleep phase issues that the PROSOMNIA Sleep Therapy is designed to improve.\n5. Failure to Respond to Conventional Sleep Treatments:\n\n   Reason: Focuses on subjects who have not found relief from existing sleep therapies, ensuring that the study population represents those in need of alternative solutions.\n6. Ability to Provide Informed Consent:\n\nReason: Ensures that participants understand the study and agree to participate voluntarily.\n\nEXCLUSION CRITERIA:\n\n1. Severe Obesity (BMI \\> 40):\n\n   Reason: Severe obesity can increase the risk of complications with anesthesia and may affect sleep patterns in ways that could confound study results.\n2. Cardiovascular Conditions:\n\n   Reason: Patients with significant heart conditions are at higher risk for complications during anesthesia.\n3. Neurological Disorders:\n\n   Reason: These diagnosed conditions and medications such as epilepsy could interfere with sleep patterns and responses to sleep therapy.\n4. Other Health Conditions Contraindicating Anesthesia:\n\n   Reason: Includes any condition that would make the use of anesthesia unsafe.\n5. Greater than ASA II Status:\n\n   Reason: The American Society of Anesthesiologists (ASA) physical status classification system classifies patients based on their pre-anesthesia medical conditions. Excluding those above ASA II ensures that only patients with mild systemic disease are included, to minimize risks.\n6. Current Use of Prohibited Medications:\n\n   Reason: Medications that could interfere with the combined use of anesthesia including, but not limited to sedatives and hypnotics; such as benzodiazepines, Z-drugs and barbiturates.\n7. Pregnancy or Breastfeeding:\n\nReason: Ensures the safety of the fetus or infant, as the effects of the PROSOMNIA Sleep therapy on pregnancy or lactation are unknown.",true,"65 Years",{"count":65,"type":22},100,[67],"PHASE1","This clinical trial aims to evaluate the safety and efficacy of PROSOMNIA Sleep Therapy (PSTx) for individuals suffering from chronic insomnia, sleep deprivation, and REM sleep disorders. Chronic insomnia, characterized by difficulty falling or staying asleep, significantly affects patients and quality of life, mood, and cognitive function. REM sleep disorders, in which the body struggles to enter or maintain restful REM sleep, can worsen these issues. The trial introduces a novel therapy using anesthesia-induced sleep, targeting sleep homeostasis and improving sleep architecture.\n\nObjectives: The primary goals of the trial are to determine:\n\n1. Whether PROSOMNIA Sleep Therapy increases the quality of REM sleep.\n2. Whether PSTx increases the duration of REM and\u002For NREM sleep.\n3. Whether PSTx decreases the time it takes participants to fall asleep (sleep onset latency).\n\nParticipants will receive ONE (1) PROSOMNIA Sleep Therapy session lasting between 60-120 minutes. Each session uses Diprivan\u002FPropofol to induce sleep, and is monitored via an EEG to ensure proper sleep stages, particularly REM sleep.\n\nParticipant Criteria:\n\nInclusion: Adults aged 18-65 with diagnosed or undiagnosed chronic insomnia or sleep deprivation.\n\nExclusion: Patients with severe obesity, significant cardiovascular, neurological, or psychiatric conditions, or those with an ASA status above II.\n\nStudy Design: This trial is non-randomized, single-arm and open-label, with all participants receiving the PSTx. The trial does not include a comparison group, as the focus is on evaluating the immediate, direct effects of the therapy.\n\nParticipants will undergo continuous EEG monitoring during therapy sessions, allowing researchers to track brain activity and sleep stages in real-time. This method ensures that sleep cycles, particularly REM sleep, are optimized for therapeutic benefit.\n\nTherapy Methodology:\n\nPROSOMNIA Sleep Therapy leverages anesthesia to mimic natural sleep patterns and enhance the efficiency of REM sleep. Diprivan\u002FPropofol is used to induce REM sleep, while EEG monitoring tracks and maintains proper sleep architecture throughout the session. The therapy promotes the clearance of adenosine, a compound that builds up during wakefulness and drives the need for sleep. Adenosine is cleared during REM sleep, reducing sleep pressure and improving cognitive function.\n\nOutcome Measures:\n\nPrimary Outcomes: Researchers will measure the increase in REM sleep duration, improvement in sleep quality (via self-reported questionnaires), and a reduction in sleep onset latency.\n\nSecondary Outcomes: These include changes in mood, cognitive function, and blood serum uric acid levels. Patient-reported outcomes will also be tracked through tools like the PROSOMNIA Sleep Quiz, which is specifically designed for PSTx.\n\nSignificance: Chronic insomnia and REM sleep disorders affect millions globally, leading to cognitive impairment, mood disturbances, and poor overall health. Traditional treatments, including pharmacological approaches and Cognitive Behavioral Therapy for Insomnia (CBT-I), often provide suboptimal results for many individuals. PSTx offers a novel, therapeutic approach to restoring sleep balance and enhancing the overall quality of sleep, particularly for those who have not responded to conventional treatments.\n\nStudy Process:\n\nRecruitment and Baseline Assessments: Participants undergo a comprehensive sleep assessment, including sleep questionnaires and polysomnography, to establish a baseline for sleep quality and duration. Blood serum uric acid levels will also be measured to track any biochemical changes due to therapy.\n\nTherapy Sessions: Only one (1) PROSOMNIA Sleep Therapy session will be administered, with the session lasting between 60-120 minutes. Diprivan\u002FPropofol is used to induce sleep, and EEG will monitor brain activity to ensure the proper balance of sleep stages.\n\nPost-Therapy Follow-up: Follow-up assessments will occur at 24 hours, 7 days, and 30 days post-treatment. Researchers will analyze the therapy effects on REM sleep, mood, cognitive function, and other health indicators.\n\nPotential Implications: If successful, this trial could revolutionize how we treat sleep disorders by targeting the underlying mechanisms of sleep pressure and REM sleep disruption. PROSOMNIA Sleep Therapy may offer a safe, effective, and immediate alternative for patients who have exhausted other treatment options.\n\nKey Concepts:\n\nHomeostatic sleep drive, (Process S), caused by adenosine buildup during wakefulness, is disrupted by chronic insomnia. This impacts cognitive function health and recovery. Anesthesia-induced REM sleep via PSTx helps regulate this homeostatic sleep stage, offering deeper and more restorative sleep compared to other sleep therapies. The study uses statistical methods like ANOVA and Chi-square to measure outcomes.",[70,71,72,73,74,75,76,77,29,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105],"Chronic Insomnia","Sleep Deprivation","REM Behavior Disorder","REM Sleep Behavior Disorder","REM Sleep Measurement","Insomnia","Insomnia Related to Specified Disorder","Insomnia Due to Other Mental Disorder","Insomnia Due to Anxiety and Fear","Insomnia Related to Another Mental Condition","Insomnia Disorders","Idiopathic Hypersomnia","Sleep Disorders, Circadian Rhythm","Post Trauma Nightmares","PTSD - Post Traumatic Stress Disorder","Sleep Quality","Anesthesia","Anxiety","Depression","Mental Health","Alzheimer Disease or Associated Disorder","Parkinsons","Circadian Rhythm","Circadian Dysregulation","PTSD","Post-Traumatic","Post-Traumatic Stress Disorder Complex","Military Combat Stress Reaction","Sleep","Military Activity","Veterans","Shift Work Sleep Disorder","Menopause Related Conditions","Pain","Cancer Pain","Athletes",[107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,75,71,125,81,126,94,89,87,88],"SLEEP","PROSOMNIA Sleep","PROSOMNIA Sleep Therapy","PSTx","PROSOMNIA","Anesthesia Sleep","REM Sleep","REM Sleep Therapy","PROSOMNIA Sleep Health","PROSOMNIA Sleep Wellness","PROSOMNIA Sleep Treatment","Nyree","Nyree Penn","Propofol","Propofol Sleep","Diprivan","Diprivan Sleep","PROSOMNIA Sleep Health and Wellness","IH","Sleep Debt","NOT_YET_RECRUITING","2025-05-27",{"date":130,"type":46},"2025-05-28",{"date":132,"type":22},"2025-11-01",{"date":134,"type":22},"2026-05-01",{"name":119,"class":136},"INDUSTRY"]