[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"comorbid-insomnia-and-sleep-apnea\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:comorbid-insomnia-and-sleep-apnea":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,56],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100657465","does-the-timing-of-insomnia-therapy-cbt-i-impact-the-usage-and-compliance-of-upper-airway-stimulation-uas-treatment-of-obstructive-sleep-apnea-osa-100657465",false,"NCT07838870","Does the Timing of Insomnia Therapy (CBT-i) Impact the Usage and Compliance of Upper Airway Stimulation (UAS) Treatment of Obstructive Sleep Apnea (OSA)","Cognitive Behavioral Therapy for Insomnia to Improve Upper Airway Stimulation Adherence in Comorbid Insomnia and Obstructive Sleep Apnea","CBT-i and UAS","Inclusion Criteria:\n\n* being seen and treated at the designated study locations for OSA with:\n* a diagnosis of insomnia (defined as ISI ≥10, or prescribed hypnotic medication (trazadone, zolpidem, eszopiclone, doxepin), or a diagnosis of insomnia \\[International Classification of Sleep Disorders 3 criteria\\]).\n* internet-capable device (e.g., smartphone, tablet, or computer)\n* able to download and use the COAST app for administration of the intervention\n* able to download and Inspire smartphone app utilized for clinical compliance information collection\n* Included patients must meet FDA indications for UAS (qualifying apnea-hypopnea index score (AHI), body mass index (AHI) and appropriate anatomical airway collapse pattern as evaluated through clinically required drug induced sleep endoscopy DISE) and be scheduled for UAS implantation in typical clinical care settings at UPMC.\n\nExclusion Criteria:\n\n* -engaged in CBT-I in past 6 months\n* does not have access to or unable to use internet capable device (smartphone, tablet or computer)","ALL","18 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"NA","Obstructive sleep apnea, or OSA, affects over 1 billion adults worldwide. OSA is one of many sleep disorders. Individuals can suffer from more than one sleep disorder at a time. Insomnia (difficulty falling or staying asleep) is a separate sleep disorder that is very often seen in OSA patients. Depending on reports, insomnia can be present in 30%-60% of patients diagnosed with OSA. This research is being conducted to determine whether treating insomnia can help patients with OSA to have better outcomes when treating their OSA.",[27,28,29],"Obstructive Sleep Apnea","Comorbid Insomnia and Sleep Apnea","Insomnia",[31,32,33,34,35,36,37,38,39,40,41,42],"obstructive sleep apnea","apnea","insomnia","comorbid insomnia and sleep apnea","upper airway stimulation","hypoglossal nerve stimulation","Noctem","University of Pittsburgh","compliance","cognitive behavioral therapy for insomnia","CBT-i","COAST","NOT_YET_RECRUITING","2026-09-18",{"date":46,"type":47},"2026-09-24","ACTUAL",{"date":49,"type":21},"2026-11-05",{"date":51,"type":21},"2028-11-30",{"name":53,"class":54},"Thomas Kaffenberger","OTHER",1,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":17,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":4,"studyType":22,"phases":68,"briefSummary":69,"conditions":70,"keywords":71,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":4},"100633025","wearable-voice-guided-bbti-for-comorbid-insomnia-and-sleep-apnea-comisa-100633025","NCT07521319","Wearable Voice-Guided BBTi for Comorbid Insomnia and Sleep Apnea (COMISA)","Wearable Voice-Guided Brief Behavioral Therapy for Insomnia (BBTi) for Comorbid Insomnia and Sleep Apnea (COMISA): Effects on Insomnia Severity and CPAP Adherence From Mechanism Evaluation and Device Development to a Multicenter Randomized Controlled Trial","BBTi-COMISA","Inclusion Criteria:\n\n* Age ≥20 years.\n* Obstructive sleep apnea (OSA) diagnosed by clinical polysomnography (PSG), defined as apnea-hypopnea index (AHI) ≥5 events\u002Fhour.\n* Insomnia disorder diagnosed by a physician according to DSM-5 criteria, with Insomnia Severity Index (ISI) score ≥15.\n* Able to understand study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* Severe cognitive impairment,\n* Major psychiatric disorder,\n* Severe chronic illness (e.g., severe heart failure or receiving hemodialysis).\n* Other sleep disorders (e.g., restless legs syndrome, narcolepsy, circadian rhythm sleep-wake disorders).\n* Receipt of CBT-I, BBTi, or other behavioral sleep interventions within the past 3 months.\n* Pregnant or breastfeeding.","20 Years","80 Years",{"count":67,"type":21},361,[24],"This study investigates the efficacy of a wearable voice-guided Brief Behavioral Therapy for Insomnia (BBTi) combined with a smart eye-mask device for individuals with Comorbid Insomnia and Sleep Apnea (COMISA). The four-year study comprises three phases: (1) exploration of cognitive-emotion regulation-arousal system mechanisms in COMISA and pilot BBTi intervention testing, (2) development and usability testing of an integrated smart eye-mask with BBTi voice-guided modules, and (3) a multi-center randomized controlled trial (RCT) evaluating the combined BBTi plus smart eye-mask intervention versus BBTi alone, smart eye-mask alone, and standard sleep hygiene education in 160 COMISA participants. Primary outcomes include insomnia severity (ISI), daytime sleepiness (ESS), and CPAP adherence. The study aims to establish an evidence-based digital health intervention for improving sleep outcomes in COMISA patients.",[28,29,27],[72,73,74,75,76],"BBTi","COMISA","CPAP","Wearable Device","Sleep","2026-04-07",{"date":79,"type":47},"2026-04-09",{"date":81,"type":21},"2026-08-01",{"date":83,"type":21},"2030-12",{"name":85,"class":54},"National Sun Yat-sen University"]