Study on the Management of COMISA (COMISA-PEC)
COMISA, the combination of obstructive sleep apnea (OSA) and insomnia, is a frequent and burdensome condition. Many patients with OSA experience clinically significant insomnia symptoms, and a substantial proportion of individuals with chronic insomnia also meet criteria for OSA. This comorbidity is associated with more severe symptoms, more complex diagnostic pathways, and reduced adherence to continuous positive airway pressure (CPAP) therapy. This study aims to better understand COMISA and evaluate whether adding daridorexant to CPAP treatment can improve treatment adherence and overall patient outcomes.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Obstructive Sleep Apnea Syndrome (OSA) and insomnia are the two most prevalent sleep disorders, and they frequently coexist. Approximately 30-50% of patients with OSA present clinically significant insomnia symptoms, while 30-40% of individuals with chronic insomnia also meet diagnostic criteria for OSA. This comorbid presentation, known as COMISA (Combined Insomnia and Sleep Apnea), has been increasingly recognized in recent research.
COMISA is associated with a higher symptom burden, greater impairment in daily functioning, and more complex diagnostic and therapeutic decision-making. Importantly, patients with COMISA show reduced acceptance and adherence to continuous positive airway pressure (CPAP) therapy compared with patients who have OSA alone. Current clinical approaches often treat each disorder separately, resulting in fragmented care rather than integrated, evidence-based management strategies tailored to COMISA.
This study aims to better characterize COMISA and explore interactions between therapeutic interventions. Specifically, it will assess whether concomitant administration of daridorexant, an orexin receptor antagonist indicated for insomnia, can improve CPAP adherence and enhance overall treatment effectiveness in patients with COMISA.
This is a minimal-risk interventional clinical trial evaluating a real-world therapeutic management strategy in patients with COMISA. Daridorexant and PAP are prescribed as part of routine care; the study-specific procedures consist of a structured follow-up.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Robin TERRAIL
- 전화번호: +33476767166
- 이메일: rterrail@chu-grenoble.fr
연구 연락처 백업
- 이름: Marie JOYEUX-FAURE, Pr
- 전화번호: +33476767166
- 이메일: mjoyeuxfaure@chu-grenoble.fr
연구 장소
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-
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Grenoble, 프랑스
- 모병
- CHU Grenoble Alpes
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연락하다:
- robin terrail
- 이메일: rterrail@chu-grenoble.fr
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Marseille, 프랑스, 13003
- 아직 모집하지 않음
- Hôpital Européen Marseille
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수석 연구원:
- Hervé PEGLIASCO, Dr
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Metz, 프랑스, 57070
- 아직 모집하지 않음
- Centre Médical Les Jasmins
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수석 연구원:
- Khier AMRANI, Dr
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Paris, 프랑스, 75013
- 아직 모집하지 않음
- Hôpital de la Pitié Salpêtrière - AP-HP
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수석 연구원:
- Maxime PATOUT, Dr
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Rennes, 프랑스, 35700
- 아직 모집하지 않음
- Polyclinique Saint-Laurent - Hospitalité Saint-Thomas de Villeneuve
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수석 연구원:
- Arnaud PRIGENT, Dr
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-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Adult patient diagnosed with COMISA, defined by an apnea-hypopnea index (AHI) ≥ 15 events/hour and an Insomnia Severity Index (ISI) score ≥ 15, newly diagnosed and naïve to CPAP therapy and daridorexant treatment (no treatment for > 5 years).
- Prescription of continuous positive airway pressure (CPAP) therapy combined with a prescription of daridorexant.
- Patient has provided informed consent to participate in the study.
- Patient is affiliated with a national health insurance system.
Exclusion Criteria:
- Severe hepatic impairment (contraindication to daridorexant treatment).
- Refusal of CPAP therapy and/or refusal of daridorexant treatment.
- Individuals covered under Articles L1121-5 to L1121-8 of the French Public Health Code.
- Staff members who have a hierarchical relationship with the principal investigator.
- Any patient who, in the opinion of the investigator, would be unable to comply with study procedures or the study schedule.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
다른: Standard therapeutic management with Daridorexant and CPAP in COMISA
Patients with COMISA receiving sequential treatment with Daridorexant and CPAP as part of routine care, with protocolized follow-up and questionnaires (IDSIQ). |
Daridorexant initiated for 1 month before CPAP and prescribed as part of routine care. PAP therapy initiated after 1 month of Daridorexant, according to standard clinical practice. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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To evaluate, in patients diagnosed with COMISA and treated with CPAP, the impact of daridorexant on CPAP adherence at 4 months compared with patients not receiving daridorexant.
기간: 4 months
|
CPAP adherence will be assessed at the 4-month routine follow-up visit and defined as the average nightly CPAP usage (hours per night) from treatment initiation to the follow-up evaluation. |
4 months
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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To evaluate, in patients diagnosed with COMISA and treated with CPAP, the impact of daridorexant on CPAP adherence at 12 months compared with patients not receiving daridorexant
기간: 12 months
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CPAP adherence will be assessed at the routine 12-month follow-up visit and defined as the average nightly CPAP usage (hours per night) from treatment initiation to the 12-month evaluation. |
12 months
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To evaluate the change in total IDSIQ score in patients with COMISA treated with CPAP and daridorexant.
기간: Baseline (Week -1 before first dose of daridorexant), Week 1 after daridorexant initiation, Week -1 before CPAP initiation, Week 1 after CPAP initiation, 4 months, 12 months.
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The variation in IDSIQ scores will be assessed across the following dimensions:
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Baseline (Week -1 before first dose of daridorexant), Week 1 after daridorexant initiation, Week -1 before CPAP initiation, Week 1 after CPAP initiation, 4 months, 12 months.
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Jean-Louis PEPIN, Pr, GRENOBLE ALPES UNIVERSITY HOSPITAL
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 2026-A01048-43
- 38RC25.0417 (기타 식별자: Grenoble Alpes University Hospital)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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