Study on the Management of COMISA

Obstructive Sleep Apnea Syndrome (OSA) and insomnia are the two most prevalent sleep disorders, and they frequently coexist. Approximately 30-50% of patients with OSA present clinically significant insomnia symptoms, while 30-40% of individuals with chronic insomnia also meet diagnostic criteria for OSA. This comorbid presentation, known as COMISA (Combined Insomnia and Sleep Apnea), has been increasingly recognized in recent research.

COMISA is associated with a higher symptom burden, greater impairment in daily functioning, and more complex diagnostic and therapeutic decision-making. Importantly, patients with COMISA show reduced acceptance and adherence to continuous positive airway pressure (CPAP) therapy compared with patients who have OSA alone. Current clinical approaches often treat each disorder separately, resulting in fragmented care rather than integrated, evidence-based management strategies tailored to COMISA.

This study aims to better characterize COMISA and explore interactions between therapeutic interventions. Specifically, it will assess whether concomitant administration of daridorexant, an orexin receptor antagonist indicated for insomnia, can improve CPAP adherence and enhance overall treatment effectiveness in patients with COMISA.

This is a minimal-risk interventional clinical trial evaluating a real-world therapeutic management strategy in patients with COMISA. Daridorexant and PAP are prescribed as part of routine care; the study-specific procedures consist of a structured follow-up.

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.