Study on the Management of COMISA | NCT07743931

NCT07743931

Overview

NCT ID: NCT07743931
Lead Sponsor: University Hospital, GrenobleOTHER
Official Title: Study on the Management of COMISA
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

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

NCT06017921Completed

Effect of Eszopiclone on Adherence to CPAP and Severity of Insomnia in Patients With COMISA

NCT07556432Not yet recruiting

Effective of Early Treatment of Insomnia on the Adherence of CPAP

NCT06568159Recruiting

Patients with Coronary Artery Disease or At High Cardiovascular Risk: Measuring Compliance with Treatment for Obstructive Sleep Apnea Syndrome

NCT05458193Completed

A Study to Investigate the Effects of Daridorexant on Nighttime Breathing in Patients With Shallow or Paused Breath During Sleep

NCT04639193Completed

Combination Drug-Therapy for Patients With Untreated Obstructive Sleep Apnea

NCT03892772Completed

Combination Pharmacological Interventions for Multiple Mechanisms of Obstructive Sleep Apnea

NCT05049928Completed

m-Rehab OSA : Impact of a Telerehabilitation Program Associated With CPAP on Severity Markers of Obstructive Sleep Apnea Syndrome

NCT05597020Completed

A Study to Find Out if Daridorexant is Safe and Efficacious in Patients With Insomnia and Comorbid Nocturia