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Study on the Management of COMISA

Study acronym: COMISA-PEC
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Jun 2028 → Sep 2028
See other at-risk trials from University Hospital, Grenoble

Record History

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  1. Recruitment opened Show 7 more changesShow less
    • Primary completion pushed from Jun 2028 to Sep 2028
    • Study completion pushed from Feb 2029 to Sep 2029
    • Study sites: 4 to 5
    • Start date changed from estimate of Aug 2026 to Sep 30, 2026
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 1 of 2 entries
    • Collaborators: details revised at 1 of 4 entries
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07743931
Lead Sponsor University Hospital, Grenoble
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
Conditions
(from sponsor)		 Obstructive Sleep Apnea (OSA), Insomnia, COMISA
Related terms Sleep Apnea, Obstructive, Sleep Initiation and Maintenance Disorders
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov