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Study on the Management of COMISA

Sponsor: University Hospital, Grenoble • ClinicalTrials.gov ID: NCT07743931

Registry updated: 2026-10-05

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Description

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.

Interventions

Daridorexant 50 mg (Drug)
Daridorexant initiated for 1 month before CPAP and prescribed as part of routine care.
Continuous Positive Air Pressure (CPAP) (Device)
PAP therapy initiated after 1 month of Daridorexant, according to standard clinical practice.

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.

Conditions

Obstructive Sleep Apnea (OSA) Insomnia COMISA

Locations

CHU Grenoble Alpes — Grenoble, France
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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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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