[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646853":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":70,"centralContacts":75,"locations":84,"responsibleParty":99,"collaborators":37,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":103,"sex":109,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":37,"studyType":115,"phases":116,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":128,"whyStopped":37,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Chulalongkorn University","OTHER",[8,16,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Lemborexant 5 mg","EXPERIMENTAL","Participants will receive two treatment sequences. Participants will complete three overnight sleep studies and cross-over with 2-week wash-out period The participants will receive lemborexant 5 mg per day before sleep for a total of 30 days. On the day 30 participants will receive the lemborexant 5 mg 5 minutes before lights-out at the sleep laboratory for overnight polysomnography. After 2 week wash-out period, the participants will cross to the placebo or lemborexant 10 mg arm with same repeat of another 2 phases.",[13,14,15],"Drug: Lemborexant 5 MG [Dayvigo] Period 1","Drug: Lemborexant 5 MG [Dayvigo] Period 2","Drug: Lemborexant 5 MG [Dayvigo] Period 3",{"label":17,"type":18,"description":19,"interventionNames":20},"Placebo","PLACEBO_COMPARATOR","Participants will receive two treatment sequences. Participants will complete three overnight sleep studies and cross-over with 2-week wash-out period The participants will receive placebo per day before sleep for a total of 30 days. On the day 30 participants will receive the placebo 5 minutes before lights-out at the sleep laboratory for overnight polysomnography. After 2 week wash-out period, the participants will cross to the lemborexant 5 or 10 mg arm with same repeat of another 2 phases.",[21,22,23],"Drug: Placebo Period 1","Drug: Placebo Period 2","Drug: Placebo Period 3",{"label":25,"type":10,"description":26,"interventionNames":27},"Lemborexant 10 mg","Participants will receive two treatment sequences. Participants will complete three overnight sleep studies and cross-over with 2-week wash-out period The participants will receive lemborexant 10 mg per day before sleep for a total of 30 days. On the day 30 participants will receive the lemborexant 10 mg 5 minutes before lights-out at the sleep laboratory for overnight polysomnography. After 2 week wash-out period, the participants will cross to the placebo or lemborexant 5 mg arm with same repeat of another 2 phases.",[28,29,30],"Drug: Lemborexant 10 MG [Dayvigo] Period 1","Drug: Lemborexant 10 MG [Dayvigo] Period 2","Drug: Lemborexant 10 MG [Dayvigo] Period 3",[32,38,42,46,50,54,58,62,66],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"DRUG","Lemborexant 5 MG [Dayvigo] Period 1","Participants will receive lemborexant 5 mg per day for 30 days during first period",[9],null,{"type":33,"name":39,"description":40,"armGroupLabels":41,"otherNames":37},"Placebo Period 1","Participants will receive placebo 5 mg per day for 30 days during the first period",[17],{"type":33,"name":43,"description":44,"armGroupLabels":45,"otherNames":37},"Lemborexant 5 MG [Dayvigo] Period 2","Participant will receive lemborexant 5 mg per day for 30 days during the second period",[9],{"type":33,"name":47,"description":48,"armGroupLabels":49,"otherNames":37},"Placebo Period 2","Participant will receive placebo 5 mg per day for 30 days during the second period",[17],{"type":33,"name":51,"description":52,"armGroupLabels":53,"otherNames":37},"Lemborexant 5 MG [Dayvigo] Period 3","Participants will receive lemborexant 5 mg per day for 30 days during third period",[9],{"type":33,"name":55,"description":56,"armGroupLabels":57,"otherNames":37},"Placebo Period 3","Participants will receive placebo per day for 30 days during third period",[17],{"type":33,"name":59,"description":60,"armGroupLabels":61,"otherNames":37},"Lemborexant 10 MG [Dayvigo] Period 1","Participants will receive lemborexant 10 mg per day for 30 days during first period",[25],{"type":33,"name":63,"description":64,"armGroupLabels":65,"otherNames":37},"Lemborexant 10 MG [Dayvigo] Period 2","Participants will receive lemborexant 10 mg per day for 30 days during second period",[25],{"type":33,"name":67,"description":68,"armGroupLabels":69,"otherNames":37},"Lemborexant 10 MG [Dayvigo] Period 3","Participants will receive lemborexant 10 mg per day for 30 days during third period",[25],[71],{"name":72,"affiliation":73,"role":74},"Sarocha Vivatvakin, MD","Department of Medicine, Faculty of Medicine","PRINCIPAL_INVESTIGATOR",[76,80],{"name":72,"role":77,"phone":78,"phoneExt":37,"email":79},"CONTACT","66879310233","sarocha.v@chula.ac.th",{"name":81,"role":77,"phone":82,"phoneExt":37,"email":83},"Naricha Chirakalwasan, MD","662-649-4037","narichac@hotmail.com",[85],{"facility":5,"status":37,"city":86,"state":87,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":97},"Pathum Wan","Bangkok","10330","Thailand","TH",{"type":92,"coordinates":93},"Point",[94,95],100.52329,13.73698,{"lat":95,"lon":94},[98],{"name":72,"role":77,"phone":78,"phoneExt":37,"email":79},{"type":100,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100646853","phase-1-the-optimal-one-month-dosing-of-lemborexant-for-moderate-obstructive-sleep-apnea-osa-patients-with-low-arousal-threshold-100646853",false,"NCT07683442","The Optimal One-Month Dosing of Lemborexant for Moderate Obstructive Sleep Apnea (OSA) Patients With Low Arousal Threshold","One-Month Dosing of Lemborexant for Treatment of Moderate OSA Patients With Low Arousal Threshold, a Randomized, Double-blind, Crossover, Placebo-Controlled Trial","LMOSALAT","Inclusion criteria\n\nIndividuals are eligible for participation in this study if they have all of the followings:\n\n1. Patient, aged 18 - 65 years at the time of informed consent\n2. Voluntary agreement and capable for giving written informed consent\n3. Diagnosis with OSA according to the criteria of the International Classification of Sleep Disorders, version 3 Text Revision\n4. Baseline screening polysomnography (PSG) demonstrated apnea-hypopnea index 15 - 30 events\u002Fh of sleep (moderate severity)\n5. Patients identified as low arousal threshold using previously recommended criteria which allocated a score of 1 to each criterion: apnea-hypopnea index \\\u003C 30 events per hour, nadir oxygen saturation as measured by pulse oximetry \\> 82.5%, and fraction of hypopneas \\> 58.3%. A score of 2 or above defined a low arousal threshold.\n6. Peripheral capillary oxygen saturation (SpO2) ≥ 94% measured during screening visit\n7. Habitually sleeping ≥ 5.5 hours\u002Fnight with usual bedtime falls within the range of 9:00 PM to 1:00 AM\n8. Body mass index 18 - 40 kg\u002Fm2 Exclusion criteria\n\nIndividuals were not eligible for participation in this study if they have any of the followings:\n\n1. Previous allergy or adverse effects with Lemborexant or other sedatives\n2. Pregnant or breastfeeding\n3. Significant medical comorbidities that could affect individual safety and study assessment results, regarding investigators' opinion\n4. Uncontrolled cardiovascular or cerebrovascular diseases\n5. Neuromuscular diseases\n6. Nasal anatomical defect\n7. Significant psychiatric comorbidities that could affect individual safety and study assessment results, regarding investigators' opinion\n8. Active respiratory disorders other than OSA\n9. Central respiratory events (CAHI) \\>25% of the total AHI\n10. Diagnosis\u002Fsymptoms of sleep-related disease other than OSA including narcolepsy, restless legs syndrome, periodic limb movement disorder, or circadian rhythm sleep-wake disorder\n11. Severe hypersomnolence (ESS ≥16)\n12. Peripheral capillary oxygen saturation (SpO2) \\\u003C 80% for ≥ 5% of total sleep time measured during screening visit\n13. Driving-related sleepiness accident or near misses in the past 12 months\n14. Safety-critical occupation\n15. Using CPAP or other dental devices within 2 weeks of screening polysomnography until the end of the study\n16. Unable to tolerate equipment in this study\n17. Taking any medication that affects sleep or other variable measured in this study\n18. Taking any medication with cytochrome P450 Family 3A (CYP3A) inhibitors and all CYP3A inducers\n19. Drug or alcohol use disorder within 2 years before the study initiation or current excessive alcohol intake\n20. Excessive caffeine intake","ALL","18 Years","65 Years",{"count":113,"type":114},36,"ESTIMATED","INTERVENTIONAL",[117,118],"PHASE1","PHASE2","The goal of this clinical trial is to investigate the 1-month treatment effects of different dose of lemborexant in moderate OSA adult patients (18-65 years of age) with low arousal threshold.\n\nThe main questions it aims to answer are:\n\nPrimary outcome measure: Apnea\u002Fhypopnea index (AHI)\n\nSecondary outcome measure:\n\n1. Polysomnography parameters\n\n   * Mean and nadir oxygen saturation\n   * Sleep efficiency\n   * Wake after sleep onset (WASO)\n   * Sleep latency\n   * Rapid eye movement (REM) latency\n   * Percentage of time spent in Non-rapid eye movement (NREM) stage 1-3 and REM stage\n   * Arousal index\n2. Oxford Sleep Resistance Test (OSLER) test\n3. Epworth Sleepiness Scale (ESS)\n4. Functional Outcome of Sleep Questionnaire-short version (FOSQ-10T)\n5. Pittsburgh Sleep Quality Index (PSQI)\n6. Actigraphy parameters\n\n   * Total sleep time\n   * Sleep efficiency\n   * Wake after sleep onset (WASO)\n   * Sleep latency\n7. Sleep diary parameters (Appendix 5)\n\n   * Total sleep time\n   * Sleep efficiency\n   * Wake after sleep onset (WASO)\n   * Sleep latency\n   * Sleep quality\n\nResearchers will compare placebo to see if there is a difference in AHI.\n\nParticipants will\n\n* participate a total of 3 phases of study (3-crossover trial)\n* each phrase the participants will receive either lemborexant 5 mg, lemborexant 10 mg, or placebo orally per day for 30 days with 2-week washout (depend on intervention arm whether the participants receive which intervention sequence)\n* complete three overnight in-laboratory polysomnography (2-week washout) at day 30 of each phrase\n* monitor actigraphy during day 1 to 29 of intervention of all periods\n* record sleep diary during day 1 to 29 of intervention of all periods\n* complete the OSLER test in the morning of the three overnight test\n* complete questionnaires including: Epworth Sleepiness Scale (ESS), Functional Outcome of Sleep Questionnaire-short version (FOSQ-10T), Pittsburgh Sleep Quality Index (PSQI) at baseline (prior to intervention) and the night before overnight in-laboratory polysomnography",[121],"OSA - Obstructive Sleep Apnea",[123,124,125,126,127],"Apnea\u002FHypopnea Index (AHI)","Lemborexant","Obstructive Sleep Apnea (OSA)","Low Arousal Threshold","Polysomnography","NOT_YET_RECRUITING","2026-07-02",{"date":131,"type":132},"2026-07-06","ACTUAL",{"date":134,"type":114},"2026-09-01",{"date":136,"type":114},"2028-06-30",{"name":5,"class":6},1]