Daridorexant 50 mg: Daridorexant initiated for 1 month before CPAP and prescribed as part of routine care.
Continuous Positive Air Pressure (CPAP): PAP therapy initiated after 1 month of Daridorexant, according to standard clinical practice.
Study 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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
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. — 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.
Trial sites (4)
Facility
City
Region
Status
Hôpital Européen Marseille
Marseille
France
Centre Médical Les Jasmins
Metz
France
Hôpital de la Pitié Salpêtrière - AP-HP
Paris
France
Polyclinique Saint-Laurent - Hospitalité Saint-Thomas de Villeneuve
Rennes
France
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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