Study on the Management of COMISA

Sponsor
University Hospital, Grenoble
Study ID
NCT07743931
Status
Not Yet Recruiting

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Conditions

  • COMISA
  • Insomnia
  • Obstructive Sleep Apnea (OSA)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Daridorexant 50 mg — DRUG
    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 Details

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.

Key Dates

First listed
Aug 4, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2028
Completion
Feb 28, 2029

Study Design

Enrollment
150 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Standard therapeutic management with Daridorexant and CPAP in COMISA
    Patients with COMISA receiving sequential treatment with Daridorexant and CPAP as part of routine care, with protocolized follow-up and questionnaires (IDSIQ).

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 ]

Central Contacts

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