Study on the Management of COMISA
NCT07743931 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2026-08-04
Summary
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.
Conditions
- Obstructive Sleep Apnea (OSA)
- Insomnia
- COMISA
Interventions
- DRUG
-
Daridorexant 50 mg
Daridorexant initiated for 1 month before CPAP and prescribed as part of routine care.
- DEVICE
-
Continuous Positive Air Pressure (CPAP)
PAP therapy initiated after 1 month of Daridorexant, according to standard clinical practice.
Sponsors & Collaborators
-
Polyclinique Saint-Laurent - Hospitalité Saint-Thomas de Villeneuve
collaborator UNKNOWN -
Hôpital Européen Marseille
collaborator OTHER -
Centre Médical les Jasmins "Poumon et Sommeil"
collaborator UNKNOWN -
Hôpital de la Pitié Salpêtrière - AP-HP
collaborator UNKNOWN -
University Hospital, Grenoble
lead OTHER
Principal Investigators
-
Jean-Louis PEPIN, Pr · GRENOBLE ALPES UNIVERSITY HOSPITAL
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-31
- Primary Completion
- 2028-06-30
- Completion
- 2029-02-28
Countries
- France
Study Locations
More Related Trials
-
Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Daridorexant in Subjects Aged 10 to < 18 Years With Insomnia Disorder
NCT05423717 ·Status: COMPLETED ·Phase: PHASE2
-
Prospective Observational Study on the Effectiveness of Daridorexant in Chronic Insomnia in a Real-World Setting
NCT07132086 ·Status: COMPLETED
-
Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep
NCT03679884 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase III Study of Eszopiclone in Patients With Insomnia (Study SEP 190-150)
NCT00770692 ·Status: COMPLETED ·Phase: PHASE3
-
Chronic Insomnia in Non-Cancer Pain Patients
NCT07057232 ·Status: RECRUITING
-
i-Sleep: Internet-based Treatment for Insomnia
NCT03110263 ·Status: TERMINATED ·Phase: NA
-
Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder
NCT03545191 ·Status: COMPLETED ·Phase: PHASE3
-
Effects of Eszopiclone and Lemborexant in People With OSA With a Low Arousal Threshold Who Have Difficulty Sleeping
NCT06928766 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Study of the Insomnia in Patients With Low Back Pain
NCT00365976 ·Status: COMPLETED ·Phase: PHASE4
-
Impact of Eszopiclone on Blood Pressure in Patients With Insomnia and Hypertension (PRYSMA-HTN)
NCT07018557 ·Status: RECRUITING ·Phase: PHASE4
-
Self Help Program for Hypnotics Withdrawal in Insomniac Patients
NCT02720458 ·Status: TERMINATED ·Phase: NA
-
The Treatment of Insomnia Comorbid With Sleep Disordered Breathing Using Armodafinil and/or Cognitive Behavioral Therapy for Insomnia
NCT02552303 ·Status: COMPLETED ·Phase: NA
-
Cognitive Behavioral Therapy for Insomnia in People With Chronic Obstructive Pulmonary Disease(COPD)
NCT01072292 ·Status: COMPLETED ·Phase: NA
-
Evaluating the Efficacy of the Management of an Online Program of Cognitive Behavioral Therapy for Primary Insomnia
NCT02539862 ·Status: COMPLETED ·Phase: NA
-
A Behavioral Therapy for Insomnia Co-existing With COPD
NCT01973647 ·Status: COMPLETED ·Phase: NA
-
Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1)
NCT02783729 ·Status: COMPLETED ·Phase: PHASE3
-
Sounds for Sleep Study in Patients Suffering From Moderate to Severe Insomnia
NCT06021795 ·Status: COMPLETED ·Phase: NA
-
A Multicenter Observational Study of Lemborexant on Insomnia Patients With Psychiatric Disorders
NCT07417813 ·Status: RECRUITING
-
The Prevalence of Insomnia in Patients With Psychiatric Disorders
NCT05408013 ·Status: COMPLETED
-
Solriamfetol and CBT-I in Patients With Insomnia Disorder
NCT05838430 ·Status: COMPLETED ·Phase: PHASE4
-
Become Your Own SLEEPexpert: a Behavioral Treatment Program for Insomnia in Patients With Psychiatric Disorders
NCT05408078 ·Status: COMPLETED ·Phase: NA
-
Internet-based Cognitive-behavioral Treatment for Insomnia in COPD Patients Undergoing Pulmonary Rehabilitation
NCT04700098 ·Status: COMPLETED ·Phase: NA
-
DREAMER - IsolateD REM Sleep Without Atonia as a Risk Factor for REM Sleep Behavior disordER
NCT06140511 ·Status: NOT_YET_RECRUITING
-
Real-World Observational Study on Patient-Reported Outcomes in the Treatment of Insomnia With Daridorexant in Canada
NCT06311864 ·Status: COMPLETED
-
Efficacy and Safety Study of Org 50081 (Esmirtazapine) in Elderly Participants (P05709)
NCT00561821 ·Status: COMPLETED ·Phase: PHASE3