| NCT ID | NCT07743931 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Grenoble |
| Condition | Obstructive Sleep Apnea (OSA) |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-09-30 |
| Primary Completion | 2028-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2026-09-30 with a primary completion date of 2028-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Jean-Louis PEPIN, Pr
PRINCIPAL INVESTIGATOR
GRENOBLE ALPES UNIVERSITY HOSPITAL
Frequently Asked Questions
Who can join the NCT07743931 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Obstructive Sleep Apnea (OSA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07743931 currently recruiting?
Yes, NCT07743931 is actively recruiting participants. Contact the research team at rterrail@chu-grenoble.fr for enrollment information.
Where is the NCT07743931 trial being conducted?
This trial is being conducted at Grenoble, France, Marseille, France, Metz, France, Paris, France and 1 additional location.
Who is sponsoring the NCT07743931 clinical trial?
NCT07743931 is sponsored by University Hospital, Grenoble. The principal investigator is Jean-Louis PEPIN, Pr at GRENOBLE ALPES UNIVERSITY HOSPITAL. The trial plans to enroll 150 participants.