Health TrialsbyHealthPanel

Study on the Management of COMISA

ConditionsObstructive Sleep Apnea (OSA)InsomniaCOMISA
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity Hospital, Grenoble

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Standard therapeutic management with Daridorexant and CPAP in COMISAOther 2 interventions

Trial outcomes

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.

Time frame
4 months

Secondary outcomes

1

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

CPAP adherence will be assessed at the routine 12-month follow-up visit and defined as the average nightly CPAP usage (hours per night) from treatment initiation to the 12-month evaluation.

Time frame
12 months
2

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

The variation in IDSIQ scores will be assessed across the following dimensions: * Effect of daridorexant: Difference between the baseline mean (week -1 before first dose of daridorexant) and the mean obtained during Week 1 after daridorexant initiation. * Effect of CPAP while on daridorexant: Difference between the mean obtained during the week preceding CPAP initiation (Week -1 before CPAP) and the mean obtained during Week 1 after CPAP initiation. * Follow-up at 4 months: Difference between the mean obtained during the week preceding the 4-month visit and the baseline mean. * Follow-up at 12 months: Difference between the mean obtained during the week preceding the 12-month visit and the baseline mean.

Time frame
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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Grenoble

Lead sponsor

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

Source ClinicalTrials.gov
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