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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Robin TERRAIL
- Número de telefone: +33476767166
- E-mail: rterrail@chu-grenoble.fr
Estude backup de contato
- Nome: Marie JOYEUX-FAURE, Pr
- Número de telefone: +33476767166
- E-mail: mjoyeuxfaure@chu-grenoble.fr
Locais de estudo
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Grenoble, França
- Recrutamento
- CHU Grenoble Alpes
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Contato:
- robin terrail
- E-mail: rterrail@chu-grenoble.fr
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Marseille, França, 13003
- Ainda não está recrutando
- Hôpital Européen Marseille
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Investigador principal:
- Hervé PEGLIASCO, Dr
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Metz, França, 57070
- Ainda não está recrutando
- Centre Médical Les Jasmins
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Investigador principal:
- Khier AMRANI, Dr
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Paris, França, 75013
- Ainda não está recrutando
- Hôpital de la Pitié Salpêtrière - AP-HP
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Investigador principal:
- Maxime PATOUT, Dr
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Rennes, França, 35700
- Ainda não está recrutando
- Polyclinique Saint-Laurent - Hospitalité Saint-Thomas de Villeneuve
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Investigador principal:
- Arnaud PRIGENT, Dr
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Outro: 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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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.
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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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
Prazo: 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.
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2026-A01048-43
- 38RC25.0417 (Outro identificador: Grenoble Alpes University Hospital)
Plano para dados de participantes individuais (IPD)
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