Study on the Management of COMISA
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity Hospital, Grenoble
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Daridorexant 50 mg
- Continuous Positive Air Pressure (CPAP)
Treatment groups
150 Participants
are divided into 1 treatment groupSponsors and collaborators
University Hospital, Grenoble
Lead sponsor
Polyclinique Saint-Laurent - Hospitalité Saint-Thomas de Villeneuve
Collaborator
Hôpital Européen Marseille
Collaborator
Centre Médical les Jasmins "Poumon et Sommeil"
Collaborator
Hôpital de la Pitié Salpêtrière - AP-HP
Collaborator
Source ClinicalTrials.gov