Obstructive Sleep Apnea (OSA)COMISA-PECNCT07743931
Study on the Management of COMISA
A study testing Daridorexant 50 mg and Continuous Positive Air Pressure (CPAP) in people with Obstructive Sleep Apnea (OSA) and Insomnia, run by University Hospital, Grenoble at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea (OSA), Insomnia, COMISA
- What is being tested?
- Daridorexant 50 mg and Continuous Positive Air Pressure (CPAP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 5 sitesFrance
- Study dates
- 30 Sep 2026to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
CHU Grenoble Alpes
Grenoble
robin terrail, rterrail@chu-grenoble.fr
- Not yet recruiting
Hôpital Européen Marseille
Marseille, 13003
Hervé PEGLIASCO, Dr
- Not yet recruiting
Centre Médical Les Jasmins
Metz, 57070
Khier AMRANI, Dr
- Not yet recruiting
Hôpital de la Pitié Salpêtrière - AP-HP
Paris, 75013
Maxime PATOUT, Dr
- Not yet recruiting
Polyclinique Saint-Laurent - Hospitalité Saint-Thomas de Villeneuve
Rennes, 35700
Arnaud PRIGENT, Dr
About this study
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea (OSA), Insomnia, COMISA
- Being tested
- Daridorexant 50 mg, Continuous Positive Air Pressure (CPAP)
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daridorexant 50 mgDrug
Daridorexant initiated for 1 month before CPAP and prescribed as part of routine care.
Continuous Positive Air Pressure (CPAP)Device
PAP therapy initiated after 1 month of Daridorexant, according to standard clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Standard therapeutic management with Daridorexant and CPAP in COMISA | Other | Patients with COMISA receiving sequential treatment with Daridorexant and CPAP as part of routine care, with protocolized follow-up and questionnaires (IDSIQ). Receives: Drug: Daridorexant 50 mg; Device: Continuous Positive Air Pressure (CPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start30 Sep 2026
- Primary completionSep 2028 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor
- Investigators
- Jean-Louis PEPIN, Pr, Principal investigator, GRENOBLE ALPES UNIVERSITY HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07743931
- Sponsor's protocol ID
- 2026-A01048-43
- Other IDs
- 38RC25.0417
- Acronym
- COMISA-PEC
- Status last verified
- Oct 2026
- First submitted
- 28 Jul 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Management of COMISA
- ClinicalTrials.gov ID
- NCT07743931
- Acronym / sponsor ID
- COMISA-PEC / 2026-A01048-43
- Conditions
- Obstructive Sleep Apnea (OSA), Insomnia, COMISA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- 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 start
- 30 Sep 2026 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard therapeutic management with Daridorexant and CPAP in COMISA | Other | Drug: Daridorexant 50 mg, Device: Continuous Positive Air Pressure (CPAP)Patients with COMISA receiving sequential treatment with Daridorexant and CPAP as part of routine care, with protocolized follow-up and questionnaires (IDSIQ). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daridorexant 50 mgDaridorexant initiated for 1 month before CPAP and prescribed as part of routine care. | Drug | Standard therapeutic management with Daridorexant and CPAP in COMISA |
| Continuous Positive Air Pressure (CPAP)PAP therapy initiated after 1 month of Daridorexant, according to standard clinical practice. | Device | Standard therapeutic management with Daridorexant and CPAP in COMISA |
Primary outcome
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.
Time frame: 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.
2 secondary outcomes
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
Time frame: 12 months
To evaluate the change in total IDSIQ score in patients with COMISA treated with CPAP and daridorexant.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Obstructive Sleep Apnea (OSA)
Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Obstructive Sleep Apnea, Cognitive Decline
RecruitingObservational study
Prevalence, Phenotypes, Predictors and Prognostic Implication of Obstructive Sleep Apnea in Pulmonary Hypertension
Sleep Apnea, Obstructive Sleep Apnea
Recruiting
Effect of Transcutaneous Electrical Stimulation on Polysomnographic Parameters in Patients With Obstructive Sleep Apnea
Obstructive Sleep Apnea
Not yet recruiting
Physical Activity, Sleep Quality, and Respiratory Function in Obstructive Sleep Apnea
Obstructive Sleep Apnea, Sleep Quality
RecruitingPhase 4
Impact GLP-1 Agonists Following Bariatric
Morbid Obesity, Metabolic Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean-Louis PEPIN, Pr principal investigator
GRENOBLE ALPES UNIVERSITY HOSPITAL
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daridorexant 50 mg and Continuous Positive Air Pressure (CPAP) in people with Obstructive Sleep Apnea (OSA) and Insomnia, run by University Hospital, Grenoble at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robin TERRAIL (+33476767166, rterrail@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.