EICHORCondition: Obstructive Sleep Apnea (OSA) · Insomnia · COMISA · Sponsor: University Hospital, Grenoble
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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.
This description comes directly from the study's public registry record.
Robin TERRAIL · +33476767166 · rterrail@chu-grenoble.fr
Marie JOYEUX-FAURE, Pr · +33476767166 · mjoyeuxfaure@chu-grenoble.fr
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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.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| 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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Source record: clinicaltrials.gov/study/NCT07743931