Study on the Management of COMISA (NCT07743931) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Study on the Management of COMISA
France150 participantsStarted 2026-08
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically for people who have both obstructive sleep apnea and insomnia at the same time — called COMISA — so could you help me understand whether I've been diagnosed with both conditions in a way that might make this trial worth discussing?
2The trial is testing whether adding a sleep medication called daridorexant helps people stick with their CPAP therapy over 4 months — given that CPAP adherence is often a struggle, do you think my current ability to tolerate CPAP would be relevant to whether this study fits my situation?
3Since this trial is listed as 'not yet recruiting,' do you know when it might open, and is it worth waiting to see if I'd be a candidate, or should we focus on starting a treatment plan now?
4The study is comparing COMISA patients who receive daridorexant alongside CPAP versus those who don't — are there already approved options for treating insomnia alongside my sleep apnea that we could consider in the meantime, before this trial becomes available?
5Because this trial doesn't have a traditional phase number, which often means it's focused more on a practical or management question than early safety testing, what do you think is still unknown about combining daridorexant with CPAP that would make participating in a study like this meaningful for patients like me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.