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Taking peopleNo phase

Study on the Management of COMISA

Key facts

Who runs it
University Hospital, Grenoble
Where
France5 sites in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
150 people, planned
Started
30 Sept 2026
Expected to end
Sept 2029
Type of study
Interventional
Treatments tested
  • Daridorexant 50 mg
  • Continuous Positive Air Pressure (CPAP)
Record updated
5 October 2026

Who can take part

Age
18 years to 75 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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 take part

  • Refusal of CPAP therapy and/or refusal of daridorexant treatment
  • Severe hepatic impairment (contraindication to 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The group in the trial

  • Standard therapeutic management with Daridorexant and CPAP in COMISAOther group

    Patients with COMISA receiving sequential treatment with Daridorexant and CPAP as part of routine care, with protocolized follow-up and questionnaires (IDSIQ).

    Treatment: Daridorexant 50 mg and Continuous Positive Air Pressure (CPAP)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Fit questions
Built from NCT07743931, who can take part
Record updated
5 October 2026