Managing COMISA: adding daridorexant to CPAP may help sleep and CPAP use

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

COMISA is the co-occurrence of obstructive sleep apnea and insomnia. This minimal-risk interventional study will look at how a sleep‑wake medication (daridorexant 50 mg) given alongside CPAP affects adherence to CPAP and overall treatment outcomes in adults with COMISA. Participants must have AHI ≥ 15 and ISI ≥ 15, be CPAP‑naïve, and have no prior daridorexant treatment. The intervention combines standard CPAP therapy with daridorexant as part of routine care, with study procedures designed to reflect real-world practice. Outcomes will inform whether this combined approach improves sleep symptoms and device use in this patient group.

Why it matters

Who can join: the full rules

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.

Where it's running

• CHU Grenoble Alpes
  Grenoble, France Recruiting
• Hôpital Européen Marseille
  Marseille, France Not yet recruiting
• Centre Médical Les Jasmins
  Metz, France Not yet recruiting
• Hôpital de la Pitié Salpêtrière - AP-HP
  Paris, France Not yet recruiting
• Polyclinique Saint-Laurent - Hospitalité Saint-Thomas de Villeneuve
  Rennes, France Not yet recruiting

Study contacts

• Principal investigator: Jean-Louis PEPIN, Pr — Grenoble Alpes University Hospital
• Study coordinator: Robin TERRAIL
• Email: rterrail@chu-grenoble.fr
• Phone: +33476767166

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.