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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Robin TERRAIL
- Número de teléfono: +33476767166
- Correo electrónico: rterrail@chu-grenoble.fr
Copia de seguridad de contactos de estudio
- Nombre: Marie JOYEUX-FAURE, Pr
- Número de teléfono: +33476767166
- Correo electrónico: mjoyeuxfaure@chu-grenoble.fr
Ubicaciones de estudio
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Grenoble, Francia
- Reclutamiento
- CHU Grenoble Alpes
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Contacto:
- robin terrail
- Correo electrónico: rterrail@chu-grenoble.fr
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Marseille, Francia, 13003
- Aún no reclutando
- Hôpital Européen Marseille
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Investigador principal:
- Hervé PEGLIASCO, Dr
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Metz, Francia, 57070
- Aún no reclutando
- Centre Médical Les Jasmins
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Investigador principal:
- Khier AMRANI, Dr
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Paris, Francia, 75013
- Aún no reclutando
- Hôpital de la Pitié Salpêtrière - AP-HP
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Investigador principal:
- Maxime PATOUT, Dr
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Rennes, Francia, 35700
- Aún no reclutando
- Polyclinique Saint-Laurent - Hospitalité Saint-Thomas de Villeneuve
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Investigador principal:
- Arnaud PRIGENT, Dr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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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.
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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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
Periodo de tiempo: 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.
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jean-Louis PEPIN, Pr, GRENOBLE ALPES UNIVERSITY HOSPITAL
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Nervioso
- Desordenes mentales
- Enfermedades de las vías respiratorias
- Trastornos de la respiración
- Trastornos del sueño y la vigilia
- Apnea
- Trastornos del Sueño Intrínsecos
- Disomnias
- Síndromes de apnea del sueño
- Apnea del Sueño Obstructiva
- Trastornos de iniciación y mantenimiento del sueño
- carro
Otros números de identificación del estudio
- 2026-A01048-43
- 38RC25.0417 (Otro identificador: Grenoble Alpes University Hospital)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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