[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Woolcock Institute of Medical Research\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":248},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,47,77,106,133,160,179,205,226],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100624141","sleepfix-for-youth-digital-behavioural-therapy-for-insomnia-with-e-psychologist-support-100624141",false,"NCT07405775","SleepFix for Youth: Digital Behavioural Therapy for Insomnia With E-Psychologist Support","iSLEEPY","Inclusion Criteria:\n\n* 16 -24 years old\n* Able to give informed online consent and if younger \\\u003C18years old guardian\u002Fparental consent\n* Insomnia Severity Index ≥ 10\n* English fluency\n* Access to a smartphone and willingness to use a mobile app for healthcare\n\nExclusion Criteria:\n\n* Shift-workers with regular shifts between the hours of 8pm and 8am.\n* Recent travel to a destination with \\>2 hours time difference (within last 7-days and with subjective reports that they are not experiencing jet lag).\n* Serious medical and\u002For psychiatric illnesses\u002Fdisorders (e.g., Epilepsy or other seizure disorders, heart failure, bipolar disorder, schizophrenia, Major Depressive disorder)\n* Self-reported\u002Fdiagnosed sleep disorders other than insomnia (e.g. - Obstructive Sleep Apnoea, REM\u002FNREM sleep disorders, Restless Leg Syndrome, Narcolepsy, free running cycle \\& Circadian rhythm disorder)\n* Currently receiving or previously received (within the last 12 months) psychotherapy for insomnia including Cognitive Behavioural Therapy (CBT).\n* Pregnant\n* Professional driver or operate heavy machinery","ALL","16 Years","24 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"NA","This pilot randomised, open-label, parallel-group controlled trial will evaluate the feasibility, acceptability and effects of a psychologist-supported digital behavioural therapy for insomnia (dBTi) compared to a wait-listed active control (digital sleep health education) in young people aged 16-24 years with insomnia symptoms.\n\nThe primary objectives are to evaluate the feasibility of conducting a full-scale trial by assessing recruitment, consent and randomisation rates, intervention uptake, and data completeness. Secondary objectives include exploring treatment effects on insomnia severity (Insomnia Severity Index), sleep diary metrics, sleep quality, fatigue, and mood (depression and anxiety symptoms). Post-intervention interviews will assess participant experience and acceptability.\n\nResults will inform the design of a larger randomised controlled trial.",[27],"Insomnia",[29,30,31,32,33,34],"young people","adolescents","insomnia","CBTi","digital behavioural therapy for insomnia","sleep restriction therapy","NOT_YET_RECRUITING","2026-02-04",{"date":38,"type":39},"2026-02-12","ACTUAL",{"date":41,"type":21},"2026-02-01",{"date":43,"type":21},"2026-12-01",{"name":45,"class":46},"Woolcock Institute of Medical Research","OTHER",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},"100623095","phase-2-understanding-the-role-of-the-locus-coeruleus-in-insomnia-100623095","NCT07392177","Understanding the Role of the Locus Coeruleus in Insomnia","An Alpha2-adrenoceptor Agonist to Reduce Locus Coeruleus Activity During Sleep in Adults With Insomnia Disorder: a Pilot Randomised Placebo-controlled Cross-over Study","LOCUSleep","Inclusion Criteria:\n\n* Diagnosis of insomnia disorder (DSM-5-TR)\n* Insomnia severity index (ISI) score ≥15\n* Able to provide informed consent\n* Fluent English literacy\n\nExclusion Criteria:\n\n* Medically diagnosis of sleep disordered breathing (i.e. sleep apnea) or sleep or circadian disorder other than insomnia\n* Uncontrolled psychiatric disorders\n* High dependence on medical care\n* History of, or current suicide ideation (Patient Health Questionnaire (PHQ-9) questionnaire)\n* Pregnancy or actively trying to conceive, or lactating\n* Shiftwork - defined as work outside of business hours (before 8am or after 6pm) conducted at least once per week\n* Travel across time zones of over 2 h time difference in the past week\n* Contraindicate the patient's participation in the clinical trial due to safety concerns or compliance with clinical study procedures\n* Concomitant use of medicines that are inhibitors, or moderate to strong inducers, of CYP3A4; regular use of hypnotics and other medications that can cause additive sedation or psychostimulants or non-amphetamine psychostimulants within 14 days of starting the clinical trial\n* Ongoing use of THC- or CBD-containing products; dependence or any other drug or alcohol dependence\n* Allergy to lactose","30 Years","65 Years",{"count":58,"type":21},15,[60],"PHASE2","This research project aims to better understand the neurobiological mechanistic underpinnings of insomnia disorder. The main question is whether cortical hyperarousal in individuals with insomnia disorder, measured by electroencephalograhic (EEG) infraslow oscillation coupling of sigma power during non-rapid eye movement (NREM) sleep and theta power during rapid eye movement (REM) sleep, is related to locus coeruleus activity.",[27],[64,65,66,67],"Electroencephalography","Sleep","Locus coeruleus","Hyperarousal","2026-01-29",{"date":70,"type":39},"2026-02-06",{"date":72,"type":21},"2026-02",{"date":74,"type":21},"2027-03",{"name":45,"class":46},1,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":76},"100559674","the-effects-of-insomnia-treatment-on-overnight-regulation-of-emotional-memories-and-risk-for-mental-disorders-100559674","NCT06567210","The Effects of Insomnia Treatment on Overnight Regulation of Emotional Memories and Risk for Mental Disorders","A Delayed-start Randomized Controlled Trial Comparing the Effects of Online Therapist-guided Cognitive Behavioural and Circadian Therapy for Insomnia Versus Control on Overnight Emotion Regulation and Mental Health Outcomes","Restless","Inclusion Criteria:\n\n* (A or B) and (C) A. Diagnosis of insomnia disorder (DSM-5-TR) B. Insomnia Severity Index (ISI) score ≥ 10 C. Generalized Anxiety Disorder (GAD-7) score ≥ 10\n* All sexes and genders.\n* Between 18 and 45 years of age.\n* Able to provide informed consent.\n* Proficient in English.\n\nExclusion Criteria:\n\nx Sleep or circadian disorder other than insomnia (e.g., hypersomnolence, periodic limb movement disorder, advanced or delayed sleep phase disorder, moderate to severe sleep apnoea disorder based on previous sleep study with an apnea-hypopnea index ≥ 15 and\u002For finger-pulse oximetry oxygen desaturation index (ODI) ≥ 10).\n\n* Current or history of neurological disorders (e.g., stroke, brain injury).\n* Current or history of bipolar disorder, psychosis, or moderate to severe obsessive-compulsive disorder.\n* Current uncontrolled mental health disorders requiring specialist care, other than major depression and anxiety disorders.\n* Centrally active agents or presence of medical condition that may affect participation.\n* Pregnancy or actively trying to conceive, or lactating.\n* Shift work for at least 2 shifts per week in the past 3 months (i.e., work between 21:00 and 6:00).\n* Travel across time zones over 3 hours difference in the previous 30 days (will require a 1-day adjustment period per hour of time zone travelled).\n* Unwilling to know about potential incidental findings.\n* No consent or adherence to instructions for any part of the study protocol.","18 Years","45 Years",{"count":88,"type":21},98,[24],"This project aims to elucidate whether CBCTi changes symptom severity or even remission of anxiety disorders as compared with a delayed-start control group. The investigators will use a delayed-start randomized controlled trial in a cohort of individuals with anxiety and insomnia (N=98) to compare the effects of an online therapist-guided cognitive behavioural and circadian therapy for insomnia versus control on overnight emotion regulation and mental health outcomes.\n\nThe project will involve at-home assessments and in-lab visits. At-home assessment involves recording sleep and circadian rhythm measures with wearables and daily diaries. Participants will be invited to perform two sleep studies and neuroimaging sessions to investigate the effects of CBCTi on neuroimaging and psychophysiological markers of overnight regulation of emotional distress.",[92,93],"Insomnia Chronic","Anxiety",[31,95,96],"anxiety","online cognitive behavioral and circadian therapy for insomnia","RECRUITING","2025-11-20",{"date":100,"type":39},"2025-11-26",{"date":102,"type":21},"2026-01-06",{"date":104,"type":21},"2030-06",{"name":45,"class":46},{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":114,"maxAge":56,"enrollmentInfo":115,"targetDuration":4,"studyType":22,"phases":117,"briefSummary":118,"conditions":119,"keywords":120,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":76},"100579396","phase-2-a-dual-orexin-receptor-antagonist-to-reduce-biomarkers-of-neurodegeneration-in-adults-with-insomnia-100579396","NCT06823752","A Dual Orexin Receptor Antagonist to Reduce Biomarkers of Neurodegeneration in Adults With Insomnia.","A Dual Orexin Receptor Antagonist to Reduce Biomarkers of Neurodegeneration in Adults With Insomnia Disorder: a Randomised Placebo-controlled Cross-over Study.","Neuro-DORA","Inclusion Criteria:\n\n* Diagnosis of insomnia disorder as defined by the DSM-5 (difficulty initiating or maintaining sleep or waking up too early for at least 3 nights per week, for at least 3 months, with adequate opportunity and circumstances for sleep and at least one daytime impairment related to the sleep difficulty) and a score ≥15 on the ISI.\n* Able to provide informed electronic consent.\n* Fluent English literacy.\n* Adults aged between 40-65 years.\n\nExclusion Criteria:\n\n* People highly dependent on medical care as determined by a medical officer.\n* Untreated moderate-severe sleep apnoea as diagnosed using in-home wrist oximetry (oxygen desaturation index\\>15, ongoing effectively treated sleep apnoea with insomnia will be allowed).\n* Circadian disorders, narcolepsy, severe restless legs syndrome, and REM sleep behaviour disorder or uncontrolled psychiatric disorders.\n* History of attempted suicide or current suicide ideation (indicated by a score \\>0 on Q9 of the Patient Health Questionnaire-9) at pre-screening.\n* Objective cognitive decline measured by scoring ≤26 on the Montreal Cognitive Assessment (MoCA)\n* Regular shift work, jet lag or trans-meridian travel (over 2h time difference) in the past week before randomisation.\n* Pregnancy or lactation. Women will be advised to use contraception for the duration of the study and a urine pregnancy test will be performed when necessary.\n* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical trial due to safety concerns or compliance with clinical study procedures.\n* Currently participating in or has participated in a research study of an investigational agent or device within 4 weeks of enrolment.\n* Concomitant use of medicines that are inhibitors (e.g., diltiazem, fluvoxamine, fluconazole, itraconazole, verapamil), or moderate to strong inducers of CYP3A4 (e.g., carbamazepine, modafinil, phenytoin, rifampicin, St John's Wort)\n* Ongoing use of anti-psychotic medication, bosentan, efavirenz, etravirine, modafinil, rifampin, carbamazepine or illicit stimulants.\n* Regular use of hypnotics (including melatonin, valerian, kava, benzodiazepines and Z-drugs), and other medications that can cause additive sedation (e.g. sedating antihistamines, tricyclic antidepressants, antipsychotics) within 14 days or 4-5 half-lives (whichever is longer) of starting the clinical trial.\n* Regular use of psychostimulants (e.g., dexamfetamine, lisdexamfetamine, methylphenidate) or non-amphetamine psychostimulants (e.g., armodafinil, modafinil, atomoxetine) within 14 days or 4-5 half-lives (whichever is longer) of starting the clinical trial.\n* Use of antidepressant medications for treatment of low mood for less than one year or dose changes (escalation or tapering) or change in antidepressant medications within the past year.\n* Regular use opioids within 14 days or 4-5 half-lives (whichever is longer) of starting the clinical trial.\n* Ongoing use of THC- or CBD-containing products within 14 days prior to the start of the trial.\n* Dependence or any other drug or alcohol dependence within the past two years (alcohol to be limited to no more than 2 standard drinks per day during trial period).\n* Allergy to lactose.","40 Years",{"count":116,"type":21},20,[60],"The goal of this clinical trial is to explore the potential neuroprotective benefits of a dual orexin receptor antagonist (DORA) in adults with insomnia. The main questions it aims to answer are:\n\n* Does the DORA reduce blood-based phosphorylated TAU181, in adults with insomnia, when compared to placebo\n* Does the DORA reduce other blood-based biomarkers of neurodegeneration, including phosphorylated TAU217, amyloid beta 40:42 ratio, Neurofilament Light Chain (NFL) and Glial Fibrillary Acidic Protein (GFAP), when compared to placebo.\n\nParticipants will:\n\n* Take 10mg Lemborexant nightly for two weeks\n* Take a matching placebo nightly for two weeks\n* Visit the research institute for a screening visit and for an overnight visit at the conclusion of each study drug treatment (3 visits in total).",[27],[121,122,123,124,65],"DORA","Tau","Beta Amyloid","Dementia","2025-09-29",{"date":127,"type":39},"2025-10-03",{"date":129,"type":39},"2025-05-13",{"date":131,"type":21},"2026-04",{"name":45,"class":46},{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":16,"minAge":141,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":22,"phases":144,"briefSummary":146,"conditions":147,"keywords":148,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":76},"100577675","early-phase-1-a-novel-inhaled-formulation-of-melatonin-to-treat-adults-with-insomnia-pharmacokinetic-study-100577675","NCT06801379","A Novel Inhaled Formulation of Melatonin to Treat Adults With Insomnia: Pharmacokinetic Study","A Novel Inhaled Formulation of Melatonin to Treat Adults With Insomnia Disorder: a Randomised Open-Label Crossover Trial","Mela-Nia","Inclusion Criteria:\n\n* Diagnosis of insomnia disorder as defined by the DSM-5 (difficulty initiating or maintaining sleep or waking up too early for at least 3 nights per week, for at least 3 months, with adequate opportunity and circumstances for sleep and at least one daytime impairment related to the sleep difficulty) and a score ≥15 on the ISI.\n* History of subjective sleep onset latency (sSOL) ≥30 minutes on at least 3 nights per week in the previous 4 weeks.\n* Able to provide informed electronic consent.\n* Fluent English literacy.\n* Adults aged 55+ years old.\n\nExclusion Criteria:\n\n* People highly dependent on medical care as determined by a medical officer.\n* Untreated moderate-severe sleep apnoea as diagnosed using in-home wrist oximetry (oxygen desaturation index\\>15, ongoing effectively treated sleep apnoea with insomnia will be allowed).\n* Circadian disorders, narcolepsy, severe restless legs syndrome, and REM sleep behaviour disorder or uncontrolled psychiatric disorders.\n* History of attempted suicide or current suicide ideation (indicated by a score \\>0 on Q9 of the Patient Health Questionnaire-9) at pre-screening.\n* Objective cognitive decline measured by scoring ≤26 on the Montreal Cognitive Assessment (MoCA)\n* Regular shift work, jet lag or trans-meridian travel (over 2h time difference) in the past week before randomisation.\n* Pregnancy or lactation. Female participants of childbearing potential with a fertile sexual partner must have a negative serum pregnancy test result at the screening visit. Women will be advised to use contraception for the duration of the study.\n* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical trial due to safety concerns or compliance with clinical study procedures.\n* Currently participating in or has participated in a research study of an investigational agent or device within 4 weeks of enrolment.\n* Ongoing use of anti-psychotic medication, bosentan, efavirenz, etravirine, modafinil, rifampin, carbamazepine or illicit stimulants.\n* Regular use of hypnotics (including melatonin, valerian, kava, benzodiazepines and Z-drugs), and other medications that can cause additive sedation (e.g. sedating antihistamines, tricyclic antidepressants, antipsychotics) within 14 days or 4-5 half-lives (whichever is longer) of starting the clinical trial.\n* Regular use of psychostimulants (e.g., dexamfetamine, lisdexamfetamine, methylphenidate) or non-amphetamine psychostimulants (e.g., armodafinil, modafinil, atomoxetine) within 14 days or 4-5 half-lives (whichever is longer) of starting the clinical trial.\n* Use of antidepressant medications for treatment of low mood for less than one year or dose changes (escalation or tapering) or change in antidepressant medications within the past year.\n* Regular use opioids within 14 days or 4-5 half-lives (whichever is longer) of starting the clinical trial.\n* Ongoing use of THC- or CBD-containing products within 14 days prior to the start of the trial.\n* Dependence or any other drug or alcohol dependence within the past two years (alcohol to be limited to no more than 2 standard drinks per day during trial period).\n* Regular use of drugs that are CYP1A2 inhibitors (e.g. amiodarone, cimetidine, ciprofloxacin, fluvoxamine) or CYP1A2 inducers (e.g. carbamazepine, phenobarbital, rifampin, tobacco).","55 Years",{"count":143,"type":21},5,[145],"EARLY_PHASE1","The goal of this clinical trial is to explore the potential benefits of an inhaled version of melatonin compared to oral melatonin tablets on adults with insomnia. The main question the trial aims to answer: is the time required for inhaled melatonin to reach peak concentration in the blood and then be eliminated from body different to that of oral melatonin tablets, in adults with insomnia?\n\n5 participants will:\n\n* Visit the research institute for a screening visit and for a daytime visit to take a melatonin treatment then provide blood samples over the course of 8 hours for each study drug treatment (3 visits in total)\n* Take 100 μg of inhaled melatonin (2 inhaler puffs) once\n* Take a 4 mg of oral melatonin (2 tablets) once",[27],[149,27,150,151],"Melatonin","Pharmacokinetics","Inhaled Therapy","2025-07-15",{"date":154,"type":39},"2025-07-18",{"date":156,"type":39},"2025-07-01",{"date":158,"type":21},"2026-05-01",{"name":45,"class":46},{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":16,"minAge":141,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":22,"phases":167,"briefSummary":168,"conditions":169,"keywords":170,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":174,"startDateStruct":175,"completionDateStruct":176,"leadSponsor":178,"locationsCount":76},"100577793","early-phase-1-a-novel-inhaled-formulation-of-melatonin-to-treat-adults-with-insomnia-efficacy-study-100577793","NCT06802913","A Novel Inhaled Formulation of Melatonin to Treat Adults With Insomnia: Efficacy Study",{"count":166,"type":21},10,[145],"The goal of this clinical trial is to explore the potential benefits of an inhaled version of melatonin compared to oral melatonin tablets on adults with insomnia. The main question the trial aims to answer is: does inhaled melatonin affect the sleep profiles of adults with insomnia differently than oral melatonin tablets?\n\n10 Participants will:\n\n* Visit the research institute for a screening visit, for an overnight visit at the beginning of each study drug treatment and for a blood collection visit at the end of the conclusion of each study drug treatment period (5 visits in total)\n* Take 100 µg of inhaled melatonin (2 inhaler puffs) nightly for two weeks\n* Take a 4 mg of oral melatonin (2 tablets) nightly for two weeks",[27],[149,27,171,172,151,173],"Polysomnography","Biomarkers","Sleep Onset Latency",{"date":154,"type":39},{"date":156,"type":39},{"date":177,"type":21},"2026-05",{"name":45,"class":46},{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":16,"minAge":185,"maxAge":186,"enrollmentInfo":187,"targetDuration":4,"studyType":189,"phases":4,"briefSummary":190,"conditions":191,"keywords":193,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":76},"100524609","detecting-heart-rate-respiration-and-sleep-with-the-sleeptracker-ai-under-mattress-monitor-100524609","NCT06110962","Detecting Heart Rate, Respiration, and Sleep With the Sleeptracker-AI Under-mattress Monitor","Inclusion Criteria:\n\n* Adults aged 20-90 years old at time of assessment.\n* Attending the Woolcock Institute for an overnight sleep study for investigation of sleep apnoea.\n* Able to give informed consent.\n* Fluent in English.\n\nExclusion Criteria:\n\n* Unable to understand study procedure.\n* Unable to sign informed consent form.","20 Years","90 Years",{"count":188,"type":21},100,"OBSERVATIONAL","The objective of this study is to simultaneously acquire sleep and breathing data using the under-mattress Sleeptracker (The Sleeptracker-AI Monitor (Fullpower Technologies, California, USA) during routine PSGs in patients who attend the Woolcock Institute for undergoing investigation for possible obstructive sleep apnoea (OSA).",[192],"OSA",[194,195,196],"validation study","Sleeptracker-AI","polysomnography","2025-03-25",{"date":199,"type":39},"2025-03-28",{"date":201,"type":39},"2024-07-10",{"date":203,"type":21},"2028-10-10",{"name":45,"class":46},{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":212,"sex":16,"minAge":85,"maxAge":56,"enrollmentInfo":213,"targetDuration":4,"studyType":22,"phases":214,"briefSummary":215,"conditions":216,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":222,"leadSponsor":224,"locationsCount":225},"100465006","cpap-and-glucose-metabolism-in-non-diabetic-osa-subjects-100465006","NCT05335083","CPAP and Glucose Metabolism in Non-Diabetic OSA Subjects","The Impact of CPAP on Glucose Metabolism in Moderate-Severe Obstructive Sleep Apnoea Patients Without Diabetes - An Observational Study","Inclusion Criteria:\n\n1. Community dwelling adult males and females aged 18-65 years\n2. Polysomnography confirmed moderate to severe OSA with apnea hypopnea index (AHI) ≥15\u002Fhr within the past 60 months\n3. Able to give written informed consent\n4. Proficient in English\n\n6\\. Diagnosed non-diabetic as defined by the American Diabetes Association as any of the following recent (\\\u003C3 months) findings:\n\n1. Fasting glucose with a BGL \\\u003C7.0 mmol\u002FL\n2. Glucose tolerance with a 2-hour BGL of \\\u003C 11.1 mmol\u002FL after a formal 75g Oral Glucose Tolerance Test (OGTT)\n3. HbA1C of ≤ 6.5% 7. Possession or regular access to a mobile telephone with capability to download and run the Withings Sleep Anlayser App.\n\nExclusion Criteria:\n\n1. Clinically significant co-morbidity (e.g. myocardial infarction, congestive heart failure, stroke, arrythmia, chronic kidney or liver disease, epilepsy, head injury)\n2. Severe mental health disorders (e.g. current major depressive disorder, schizophrenia, bipolar disorder) that in the opinion of the investigator is not adequately treated or will significantly affect their participation in the study.\n3. Regular (\\>2 times per month) use of sleep-affecting medication (e.g. benzodiazepines, opioids, antidepressants)\n4. Regular night shift work or travel overseas within the last 2 weeks\n5. Sleep physician has advised against CPAP withdrawal\n6. Pregnancy\n7. Active smoking or routine alcohol use (more than 2 standard drinks a day) or excessive caffeine intake (\\>300 mg a day) or recent (in the past month) use of illicit drugs\n8. Current or previous diagnosis of diabetes mellitus (previous gestational diabetes mellitus not excluded)\n9. Current or recent (\\\u003C3 months) use of hypoglycaemic agents\n10. Undergoing a weight loss programme\n11. Contraindications for use of the FreeStyle Libre Pro Sensor. E.g. Known hypersensitivity to skin adhesives such as those used to attach the sensor to the arm.",true,{"count":188,"type":21},[24],"The purpose of the current study is to investigate whether alleviation of OSA by CPAP positively impacts glucose metabolism in non-diabetic patients.",[217,218],"Obstructive Sleep Apnea","Pre-diabetes",{"date":220,"type":39},"2025-04-01",{"date":156,"type":21},{"date":223,"type":21},"2027-02-28",{"name":45,"class":46},2,{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":230,"acronym":231,"eligibilityCriteria":232,"healthyVolunteers":11,"sex":16,"minAge":85,"maxAge":4,"enrollmentInfo":233,"targetDuration":4,"studyType":22,"phases":235,"briefSummary":236,"conditions":237,"keywords":238,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":76},"100524912","efficacy-of-mobile-delivered-sleep-restriction-therapy-for-treatment-of-insomnia-disorder-randomised-controlled-trial-100524912","NCT06114901","Efficacy of Mobile-delivered Sleep Restriction Therapy for Treatment of Insomnia Disorder: Randomised Controlled Trial","SleepFix","Inclusion Criteria:\n\n* Adults aged ≥ 18 years\n* Able to give informed online consent\n* Insomnia Severity Index ≥ 12\n* English fluency\n* Access to a smartphone and willingness\u002Fproficiency to use a mobile application\n\nExclusion Criteria:\n\n* Shift-workers (at least 2 night shifts a week between the hours of 8 pm to 8 am)\n* Serious medical and\u002For psychiatric illnesses\u002Fdisorders\n* Previously diagnosed or suspected\u002Fhigh-risk of undiagnosed sleep disorders (e.g. REM Sleep Behaviour Disorder, Restless Leg Syndrome\n* Currently receiving Cognitive Behavioural Therapy for insomnia (CBT-i)\n* Operators of machinery that require high alertness (e.g. truck drivers, train drivers, pilots, etc)\n* Pregnant women",{"count":234,"type":21},558,[24],"The \"SleepFix Study\" is a clinical trial designed to evaluate the efficacy of mobile-delivered sleep restriction therapy (dBTi) in comparison to digital sleep health education (control) for treating insomnia disorder in adults aged 18 and above. The study is conducted entirely online, with 558 participants (279 in each group) and aims to determine the impact of the interventions on insomnia symptom severity, sleep metrics, subjective sleep quality, fatigue, anxiety, depressive symptoms, quality of life, medication usage, and workforce productivity.",[27],[32,239,27],"Digital CBTi","2024-07-14",{"date":242,"type":39},"2024-07-16",{"date":244,"type":21},"2025-02-01",{"date":246,"type":21},"2028-10-26",{"name":45,"class":46},""]