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Sleep Apnea Biomarkers and Adherence to Continuous Positive Airway Pressure (BIOSA)

26 août 2026 mis à jour par: Bughin Francois, Clinique du Millenaire

Impact of Obstructive Sleep Apnea Biomarkers on Adherence to Continuous Positive Airway Pressure: Role of Pulse Wave Amplitude Drop Index, Hypoxic Burden, and Heart Rate Variability

Obstructive sleep apnea (OSA) is commonly assessed using the apnea-hypopnea index, although this measure does not fully reflect cardiovascular risk or the physiological impact of the disease. Emerging biomarkers, including sleep apnea-specific hypoxic burden, pulse wave amplitude drop index, and heart rate response, may provide additional information on cardiovascular vulnerability.

This prospective multicenter observational study will investigate the association between these biomarkers, measured from the diagnostic sleep study, and adherence to continuous positive airway pressure (CPAP) therapy after three months. Symptoms, quality of life, clinical characteristics, and changes in biomarkers under continuous positive airway pressure will also be evaluated.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

This is a prospective, longitudinal, multicenter observational cohort study involving adults with newly diagnosed obstructive sleep apnea for whom continuous positive airway pressure therapy is indicated as part of routine clinical care.

At baseline, demographic and clinical characteristics, medical history, current treatments, symptom questionnaires, and results from diagnostic respiratory polygraphy or polysomnography will be collected. Hypoxic burden, pulse wave amplitude drop index, and heart rate response will be calculated from the initial sleep recording. Continuous positive airway pressure will be prescribed according to standard clinical practice.

At 12 weeks, with a permitted window of plus or minus four weeks, adherence data will be obtained from the continuous positive airway pressure device. Clinical information and questionnaires will be collected again. Participants requiring a follow-up sleep study as part of routine care may undergo respiratory polygraphy or polysomnography while receiving continuous positive airway pressure, allowing assessment of biomarker changes under treatment.

The principal analysis will examine associations between baseline biomarkers and continuous positive airway pressure adherence. Secondary analyses will assess biomarker distributions according to clinical characteristics, associations with symptoms and quality of life, and changes in biomarkers during treatment.

Type d'étude

Observationnel

Inscription (Estimé)

200

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Francois FB Bughin, MD, PhD
  • Numéro de téléphone: 0033761783081
  • E-mail: fbughin@hotmail.com

Lieux d'étude

  • France
      • Montpellier, France, 34000
        • Recrutement
        • Clinique Millenaire
        • Contact:
          • Francois FB Bughin, Study Principal Investigator
          • Numéro de téléphone: 0033761783081
          • E-mail: fbughin@hotmail.com

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Adults with newly diagnosed obstructive sleep apnea syndrome and an indication for continuous positive airway pressure therapy, recruited from approximately 10 sleep medicine centers in France. Participants are treated according to routine clinical practice and followed for 3 months to assess CPAP adherence, symptoms, quality of life, and sleep apnea biomarkers.

La description

Inclusion Criteria:

  • Newly diagnosed obstructive sleep apnea with an indication for continuous positive airway pressure therapy
  • Age older than 18 years
  • Written informed consent obtained

Exclusion Criteria:

  • Continuous positive airway pressure treatment during the preceding 3 months
  • Medical contraindication to continuous positive airway pressure therapy
  • Concomitant condition likely to affect adherence to continuous positive airway pressure, including severe cognitive impairment or an unstable psychiatric disorder

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Patients with newly diagnosed obstructive sleep apnea
Adults with newly diagnosed obstructive sleep apnea and a clinical indication for continuous positive airway pressure therapy. Treatment is prescribed according to routine clinical practice. Participants are followed for three months to evaluate treatment adherence, symptoms, quality of life, and sleep apnea biomarkers.
Dispositif: Continuous Positive Airway Pressure
Continuous positive airway pressure prescribed as part of routine clinical care according to applicable clinical recommendations. The study does not assign the treatment or its settings.
Autres noms:
  • CPAP
  • Pression positive des voies respiratoires

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Association Between Baseline Hypoxic Burden and CPAP Adherence at 3 Months
Délai: Baseline to 3 months after CPAP initiation
Association between hypoxic burden measured during the baseline diagnostic sleep study and mean nightly CPAP use during the 30 days preceding the 3-month visit. CPAP adherence will also be categorized as less than 4 hours per night versus 4 hours or more per night.
Baseline to 3 months after CPAP initiation

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Distribution of Baseline Sleep Apnea Biomarkers
Délai: BASELINE
Distribution of hypoxic burden, pulse wave amplitude drop index, and heart rate response measured or calculated from the baseline respiratory polygraphy or polysomnography. Results will be described according to sex, age, body mass index, medical history, cardiovascular history, and current treatments.
BASELINE
Association Between Baseline Heart Rate Response and CPAP Adherence at 3 Months
Délai: Baseline to 3 months after CPAP initiation
Association between the heart rate response to respiratory events (delta heart rate) measured during the baseline diagnostic sleep study and mean nightly CPAP use during the 30 days preceding the 3-month visit. CPAP adherence will also be categorized as less than 4 hours per night versus 4 hours or more per night.
Baseline to 3 months after CPAP initiation
Association Between Baseline Pulse Wave Amplitude Drop Index and CPAP Adherence at 3 Months
Délai: Baseline to 3 months after CPAP initiation
Association between the pulse wave amplitude drop index (PWAD index) measured during the baseline diagnostic sleep study and mean nightly CPAP use during the 30 days preceding the 3-month visit. CPAP adherence will also be categorized as less than 4 hours per night versus 4 hours or more per night.
Baseline to 3 months after CPAP initiation
Daytime Sleepiness Assessed by the Epworth Sleepiness Scale
Délai: Baseline and 3 months
Daytime sleepiness will be assessed using the Epworth Sleepiness Scale at baseline and 3 months after CPAP initiation. The total score ranges from 0 to 24, with higher scores indicating greater daytime sleepiness and therefore a worse outcome. The change in total score between baseline and 3 months will be evaluated.
Baseline and 3 months
Health-Related Quality of Life Assessed Using the EuroQol 5-Dimension 5-Level Questionnaire
Délai: baseline and 3 months
Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) at baseline and 3 months after CPAP initiation. The EQ-5D-5L evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels, ranging from 1 (no problems) to 5 (extreme problems or inability to perform the activity). Responses will be converted into an EQ-5D-5L utility index using the French value set. Index values range from -0.525 to 1, with higher values indicating better health-related quality of life. The change in the utility index between baseline and 3 months will be evaluated.
baseline and 3 months
Goal Attainment Assessed by Goal Attainment Scaling
Délai: baseline and 3 months
Goal Attainment Scaling score and its change between baseline and the 3-month follow-up visit. Attainment of the participant's individualized treatment goal will be assessed at 3 months using Goal Attainment Scaling (GAS). Goal attainment is rated on a five-point scale ranging from -2 to +2: -2 indicates a much worse outcome than expected, -1 a somewhat worse outcome than expected, 0 the expected level of goal attainment, +1 a somewhat better outcome than expected, and +2 a much better outcome than expected. Higher scores indicate better goal attainment and therefore a better outcome
baseline and 3 months
Change in Sleep Apnea-Specific Hypoxic Burden During CPAP Therapy
Délai: baseline and 3 months
Sleep apnea-specific hypoxic burden will be calculated from the oxygen desaturation area associated with respiratory events and expressed as percent-minutes per hour (%min/h). The change from the baseline diagnostic sleep study to the sleep study performed during CPAP therapy at 3 months will be evaluated. Higher values indicate a greater hypoxic burden and therefore a worse outcome. This assessment will be performed only in participants undergoing a follow-up sleep study as part of routine care.
baseline and 3 months
Change in Pulse Wave Amplitude Drop Index During CPAP Therapy
Délai: Baseline and 3 months after CPAP initiation
The pulse wave amplitude drop index will be calculated as the number of pulse wave amplitude drops per hour of sleep or recording. The change from the baseline diagnostic sleep study to the sleep study performed during CPAP therapy at 3 months will be evaluated. Higher values indicate more frequent pulse wave amplitude drops. This assessment will be performed only in participants undergoing a follow-up sleep study as part of routine care.
Baseline and 3 months after CPAP initiation
Change in Heart Rate Response to Respiratory Events During CPAP Therapy
Délai: Baseline and 3 months after CPAP initiation
Heart rate response will be measured as the mean change in heart rate associated with respiratory events (delta heart rate). The change from the baseline diagnostic sleep study to the sleep study performed during CPAP therapy at 3 months will be evaluated. Higher values indicate a greater heart rate response to respiratory events. This assessment will be performed only in participants undergoing a follow-up sleep study as part of routine care.
Baseline and 3 months after CPAP initiation

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Clinique du Millenaire

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

18 février 2026

Achèvement primaire (Estimé)

31 décembre 2026

Achèvement de l'étude (Estimé)

30 septembre 2027

Dates d'inscription aux études

Première soumission

10 août 2026

Première soumission répondant aux critères de contrôle qualité

26 août 2026

Première publication (Réel)

28 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

28 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

26 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • BIOSA
  • 2025-A01061-48 (Autre identifiant: French National Agency for the Safety of Medicines and Health Products (ANSM))

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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