Study on the Management of COMISA

NCT07743931 | Not Yet Recruiting

• 2 other identifiers: 2026-A01048-4338RC25.0417
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Obstructive Sleep Apnea (OSA); Insomnia; COMISA

Outcome Measures

Primary Outcomes (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.

  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.

  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

  12 months

• To evaluate the change in total IDSIQ score in patients with COMISA treated with CPAP and daridorexant.

  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.

Study Arms (1)

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).

Drug: Daridorexant 50 mg; Device: Continuous Positive Air Pressure (CPAP)

Interventions

Daridorexant 50 mg DRUG

Daridorexant initiated for 1 month before CPAP and prescribed as part of routine care.

Standard therapeutic management with Daridorexant and CPAP in COMISA

Continuous Positive Air Pressure (CPAP) DEVICE

PAP therapy initiated after 1 month of Daridorexant, according to standard clinical practice.

Standard therapeutic management with Daridorexant and CPAP in COMISA

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Polyclinique Saint-Laurent - Hospitalité Saint-Thomas de Villeneuve: collaborator
• Hôpital Européen Marseille: collaborator
• Centre Médical les Jasmins "Poumon et Sommeil": collaborator
• Hôpital de la Pitié Salpêtrière - AP-HP: collaborator

Study Sites (4)

Hôpital Européen Marseille

Marseille, 13003, France

Location

Centre Médical Les Jasmins

Metz, 57070, France

Location

Hôpital de la Pitié Salpêtrière - AP-HP

Paris, 75013, France

Location

Polyclinique Saint-Laurent - Hospitalité Saint-Thomas de Villeneuve

Rennes, 35700, France

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Initiation and Maintenance Disorders

Interventions

daridorexant

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Jean-Louis PEPIN, Pr

  GRENOBLE ALPES UNIVERSITY HOSPITAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robin TERRAIL

CONTACT

+33476767166; rterrail@chu-grenoble.fr

Marie JOYEUX-FAURE, Pr

CONTACT

+33476767166; mjoyeuxfaure@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 4, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: August 4, 2026

Record last verified: 2026-07

Locations

FR (4)