[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635726":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":40,"collaborators":26,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":46,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":26,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":72,"whyStopped":26,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":26},{"fullName":5,"class":6},"Centre Hospitalier Universitaire Vaudois","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CPAP","ACTIVE_COMPARATOR","CPAP + usual care",[13],"Device: CPAP",{"label":15,"type":16,"description":17,"interventionNames":18},"CPAP + CBT-I","EXPERIMENTAL","CPAP + cognitive behavorial therapy for insomnia",[19,13],"Behavioral: digital CBT-I",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","digital CBT-I","The investigators add digital CBT-I intervention for the CPAP + CBT-I group",[15],null,{"type":28,"name":9,"description":29,"armGroupLabels":30,"otherNames":26},"DEVICE","CPAP as usual",[9,15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Geoffroy OB Solelhac","CONTACT","+41213146748","geoffroy.solelhac@chuv.ch",{"name":38,"role":34,"phone":35,"phoneExt":26,"email":39},"Isabel Maceira Ericson","isabel.ericson@chuv.ch",{"type":41,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Solelhac Geoffroy","Dr","100635726","effective-of-early-treatment-of-insomnia-on-the-adherence-of-cpap-100635726",false,"NCT07556432","Effective of Early Treatment of Insomnia on the Adherence of CPAP","Comorbid Insomnia and Sleep Apnea (COMISA): Can Early Treatment of Insomnia Improve Adherence to CPAP Therapy?","CoPAP","Inclusion criteria:\n\n1. 45-65 years of age\n2. Diagnosis of OSAS by respiratory polygraphy or polysomnography with an apnea-hypopnea index (AHI) ≥20 when scored by PSG or ≥15 when scored by PG30 with a prescription for CPAP therapy\n3. Diagnosis of chronic insomnia according to the International Classification of Sleep Disorders (ICSD 3-TR).31\n4. Ability to communicate in French\n5. Ability to provide informed consent\n6. Accept to receive information about incidental findings\n7. Ownership of a smartphone running at least Android 9 (API version 28+) or iOS 12.2+.\n\nExclusion criteria:\n\n1. Current treatment for OSAS\n2. Current or past treatment for chronic insomnia (CBT-I)\n3. Severe restless legs syndrome\n4. REM sleep behaviour disorder\n5. Neurological diseases (stroke, Parkinson's disease, etc.)\n6. Severe hypertension (≥180 mmHg systolic or requiring ≥3 antihypertensive medications)\n7. Respiratory failure (oxygen saturation during wakefulness \\\u003C90%)\n8. Severe heart failure (NYHA class III-IV)\n9. High-risk alcohol consumption (≥14 units\u002Fweek)\n10. Known pregnancy\n11. Epilepsy or history of epileptic seizures (ICD-11: 8A6; ICD-10: G40)\n12. Known bipolar disorder of any type (ICD-11: 6A60, 6A61, 6A6Y, 6A6Z; ICD-10: F31)\n13. Known Acute and transient psychotic disorder (ICD-11: 6A23; ICD-10: F23)\n14. Known Active suicidal ideation\n15. Known or suspected severe parasomnias incompatible with programme use (e.g., sleepwalking:\n16. Known Severe cardiovascular disease that may contraindicate unsupervised CBT-I strategies (e.g., unstable arrhythmias, angina pectoris)\n17. Any medical or psychiatric condition that, in the investigator's judgment, would contraindicate the use of the CE-marked HelloBetter Insomnie digital device or participation in CBT-I","ALL","45 Years","65 Years",{"count":56,"type":57},120,"ESTIMATED","INTERVENTIONAL",[60],"NA","This study includes patients suffering from both sleep apnea and insomnia. All participants receive treatment with CPAP. Half of the participants additionally receive a digital program to treat insomnia, initiated at the same time as CPAP. The other half follows usual care and will be able to access the program after 6 months. The aim is to determine whether treating insomnia earlier improves CPAP use and overall health.",[63,64],"Obstructive Sleep Apnea (OSA)","Insomnia Chronic",[66,67,9,68,69,70,71],"Obstructive sleep apnea","OSA","COMISA","cognitve behavorial therapy for insomnia","cognitive health","cardiovascular health","NOT_YET_RECRUITING","2026-04-22",{"date":75,"type":76},"2026-04-29","ACTUAL",{"date":78,"type":57},"2026-06-01",{"date":80,"type":57},"2028-12-31",{"name":5,"class":6}]