An interventional study of Daridorexant 50 mg and Continuous Positive Air Pressure (CPAP) in Obstructive Sleep Apnea (OSA), Insomnia and COMISA, sponsored by University Hospital, Grenoble. Recruiting at 5 sites in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by University Hospital, Grenoble · Not applicable, Interventional, and Treatment
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.
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.
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's planned enrollment of 150 is above the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →University Hospital, Grenoble is the lead sponsor of 837 studies on the registry; 207 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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Patients with COMISA receiving sequential treatment with Daridorexant and CPAP as part of routine care, with protocolized follow-up and questionnaires (IDSIQ).
Drug: Daridorexant 50 mg · Device: Continuous Positive Air Pressure (CPAP)
Daridorexant initiated for 1 month before CPAP and prescribed as part of routine care.
PAP therapy initiated after 1 month of Daridorexant, according to standard clinical practice.
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.
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.
Time frame: 4 months
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
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.
Time frame: 12 months
To evaluate the change in total IDSIQ score in patients with COMISA treated with CPAP and daridorexant.
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.
Time frame: 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.
Plan to share: Undecided
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Started Sep 2026 (actual). Primary completion is estimated for Sep 2028, 24 months after the start.
Of 508 non-industry interventional studies with no phase under Sleep Apnea, Obstructive, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 24 months is below that.
Counting every sponsor, half of 623 studies reached it within 27 months; a quarter within 12 and three quarters within 50.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 5, 2026: start Aug 2026 → Sep 2026, primary completion Jun 2028 → Sep 2028 and completion Feb 2029 → Sep 2029.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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