Obstructive Sleep Apnea (OSA), Insomnia, COMISA
Conditions
Brief 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.
Detailed description
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.
Interventions
Daridorexant initiated for 1 month before CPAP and prescribed as part of routine care.
DEVICEContinuous Positive Air Pressure (CPAP)
PAP therapy initiated after 1 month of Daridorexant, according to standard clinical practice.
Sponsors
University Hospital, Grenoble
Polyclinique Saint-Laurent - Hospitalité Saint-Thomas de Villeneuve
Hôpital Européen Marseille
Centre Médical les Jasmins "Poumon et Sommeil"
Hôpital de la Pitié Salpêtrière - AP-HP
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate, in patients diagnosed with COMISA and treated with CPAP, the impact of daridorexant on CPAP adherence at 12 months compared with patients not receiving daridorexant | 12 months | CPAP adherence will be assessed at the routine 12-month follow-up visit and defined as the average nightly CPAP usage (hours per night) from treatment initiation to the 12-month evaluation. |
| To evaluate the change in total IDSIQ score in patients with COMISA treated with CPAP and daridorexant. | Baseline (Week -1 before first dose of daridorexant), Week 1 after daridorexant initiation, Week -1 before CPAP initiation, Week 1 after CPAP initiation, 4 months, 12 months. | The variation in IDSIQ scores will be assessed across the following dimensions: * Effect of daridorexant: Difference between the baseline mean (week -1 before first dose of daridorexant) and the mean obtained during Week 1 after daridorexant initiation. * Effect of CPAP while on daridorexant: Difference between the mean obtained during the week preceding CPAP initiation (Week -1 before CPAP) and the mean obtained during Week 1 after CPAP initiation. * Follow-up at 4 months: Difference between the mean obtained during the week preceding the 4-month visit and the baseline mean. * Follow-up at 12 months: Difference between the mean obtained during the week preceding the 12-month visit and the baseline mean. |
Countries
France
Contacts
CONTACTRobin TERRAIL
CONTACTMarie JOYEUX-FAURE, Pr
PRINCIPAL_INVESTIGATORJean-Louis PEPIN, Pr
GRENOBLE ALPES UNIVERSITY HOSPITAL
Outcome results
None listed