Study on the Management of COMISA (COMISA-PEC)
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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Obstructive Sleep Apnea Syndrome (OSA) and insomnia are the two most prevalent sleep disorders, and they frequently coexist. Approximately 30-50% of patients with OSA present clinically significant insomnia symptoms, while 30-40% of individuals with chronic insomnia also meet diagnostic criteria for OSA. This comorbid presentation, known as COMISA (Combined Insomnia and Sleep Apnea), has been increasingly recognized in recent research.
COMISA is associated with a higher symptom burden, greater impairment in daily functioning, and more complex diagnostic and therapeutic decision-making. Importantly, patients with COMISA show reduced acceptance and adherence to continuous positive airway pressure (CPAP) therapy compared with patients who have OSA alone. Current clinical approaches often treat each disorder separately, resulting in fragmented care rather than integrated, evidence-based management strategies tailored to COMISA.
This study aims to better characterize COMISA and explore interactions between therapeutic interventions. Specifically, it will assess whether concomitant administration of daridorexant, an orexin receptor antagonist indicated for insomnia, can improve CPAP adherence and enhance overall treatment effectiveness in patients with COMISA.
This is a minimal-risk interventional clinical trial evaluating a real-world therapeutic management strategy in patients with COMISA. Daridorexant and PAP are prescribed as part of routine care; the study-specific procedures consist of a structured follow-up.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Robin TERRAIL
- Telefonnummer: +33476767166
- E-post: rterrail@chu-grenoble.fr
Studer Kontakt Backup
- Navn: Marie JOYEUX-FAURE, Pr
- Telefonnummer: +33476767166
- E-post: mjoyeuxfaure@chu-grenoble.fr
Studiesteder
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Grenoble, Frankrike
- Rekruttering
- CHU Grenoble Alpes
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Ta kontakt med:
- robin terrail
- E-post: rterrail@chu-grenoble.fr
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Marseille, Frankrike, 13003
- Har ikke rekruttert ennå
- Hôpital Européen Marseille
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Hovedetterforsker:
- Hervé PEGLIASCO, Dr
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Metz, Frankrike, 57070
- Har ikke rekruttert ennå
- Centre Médical Les Jasmins
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Hovedetterforsker:
- Khier AMRANI, Dr
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Paris, Frankrike, 75013
- Har ikke rekruttert ennå
- Hôpital de la Pitié Salpêtrière - AP-HP
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Hovedetterforsker:
- Maxime PATOUT, Dr
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Rennes, Frankrike, 35700
- Har ikke rekruttert ennå
- Polyclinique Saint-Laurent - Hospitalité Saint-Thomas de Villeneuve
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Hovedetterforsker:
- Arnaud PRIGENT, Dr
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Annen: 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). |
Daridorexant initiated for 1 month before CPAP and prescribed as part of routine care. PAP therapy initiated after 1 month of Daridorexant, according to standard clinical practice. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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.
Tidsramme: 4 months
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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
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
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
Tidsramme: 12 months
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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. |
12 months
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To evaluate the change in total IDSIQ score in patients with COMISA treated with CPAP and daridorexant.
Tidsramme: 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.
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The variation in IDSIQ scores will be assessed across the following dimensions:
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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.
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Jean-Louis PEPIN, Pr, GRENOBLE ALPES UNIVERSITY HOSPITAL
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2026-A01048-43
- 38RC25.0417 (Annen identifikator: Grenoble Alpes University Hospital)
Plan for individuelle deltakerdata (IPD)
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