Sleep Apnea Biomarkers and Adherence to Continuous Positive Airway Pressure (BIOSA)
26 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Estimado)
200
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Francois FB Bughin, MD, PhD
- Número de teléfono: 0033761783081
- Correo electrónico: fbughin@hotmail.com
Ubicaciones de estudio
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Montpellier, Francia, 34000
- Reclutamiento
- Clinique Millenaire
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Contacto:
- Francois FB Bughin, Study Principal Investigator
- Número de teléfono: 0033761783081
- Correo electrónico: fbughin@hotmail.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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.
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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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Association Between Baseline Hypoxic Burden and CPAP Adherence at 3 Months
Periodo de tiempo: Baseline to 3 months after CPAP initiation
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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.
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Baseline to 3 months after CPAP initiation
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Distribution of Baseline Sleep Apnea Biomarkers
Periodo de tiempo: BASELINE
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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.
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BASELINE
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Association Between Baseline Heart Rate Response and CPAP Adherence at 3 Months
Periodo de tiempo: Baseline to 3 months after CPAP initiation
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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.
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Baseline to 3 months after CPAP initiation
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Association Between Baseline Pulse Wave Amplitude Drop Index and CPAP Adherence at 3 Months
Periodo de tiempo: Baseline to 3 months after CPAP initiation
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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.
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Baseline to 3 months after CPAP initiation
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Daytime Sleepiness Assessed by the Epworth Sleepiness Scale
Periodo de tiempo: Baseline and 3 months
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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.
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Baseline and 3 months
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Health-Related Quality of Life Assessed Using the EuroQol 5-Dimension 5-Level Questionnaire
Periodo de tiempo: baseline and 3 months
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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.
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baseline and 3 months
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Goal Attainment Assessed by Goal Attainment Scaling
Periodo de tiempo: baseline and 3 months
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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
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baseline and 3 months
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Change in Sleep Apnea-Specific Hypoxic Burden During CPAP Therapy
Periodo de tiempo: baseline and 3 months
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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.
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baseline and 3 months
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Change in Pulse Wave Amplitude Drop Index During CPAP Therapy
Periodo de tiempo: Baseline and 3 months after CPAP initiation
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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.
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Baseline and 3 months after CPAP initiation
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Change in Heart Rate Response to Respiratory Events During CPAP Therapy
Periodo de tiempo: Baseline and 3 months after CPAP initiation
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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.
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Baseline and 3 months after CPAP initiation
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Gagnadoux F, Bequignon E, Prigent A, Micoulaud-Franchi JA, Chambe J, Texereau J, Alami S, Roche F. The PAP-RES algorithm: Defining who, why and how to use positive airway pressure therapy for OSA. Sleep Med Rev. 2024 Jun;75:101932. doi: 10.1016/j.smrv.2024.101932. Epub 2024 Apr 8.
- Pinilla L, Esmaeili N, Labarca G, Martinez-Garcia MA, Torres G, Gracia-Lavedan E, Minguez O, Martinez D, Abad J, Masdeu MJ, Mediano O, Munoz C, Cabriada V, Duran-Cantolla J, Mayos M, Coloma R, Montserrat JM, de la Pena M, Hu WH, Messineo L, Sehhati M, Wellman A, Redline S, Sands S, Barbe F, Sanchez-de-la-Torre M, Azarbarzin A. Hypoxic burden to guide CPAP treatment allocation in patients with obstructive sleep apnoea: a post hoc study of the ISAACC trial. Eur Respir J. 2023 Dec 7;62(6):2300828. doi: 10.1183/13993003.00828-2023. Print 2023 Dec.
- Gerves-Pinquie C, Bailly S, Goupil F, Pigeanne T, Launois S, Leclair-Visonneau L, Masson P, Bizieux-Thaminy A, Blanchard M, Sabil A, Jaffuel D, Racineux JL, Trzepizur W, Gagnadoux F. Positive Airway Pressure Adherence, Mortality, and Cardiovascular Events in Patients with Sleep Apnea. Am J Respir Crit Care Med. 2022 Dec 1;206(11):1393-1404. doi: 10.1164/rccm.202202-0366OC.
- McEvoy RD, Antic NA, Heeley E, Luo Y, Ou Q, Zhang X, Mediano O, Chen R, Drager LF, Liu Z, Chen G, Du B, McArdle N, Mukherjee S, Tripathi M, Billot L, Li Q, Lorenzi-Filho G, Barbe F, Redline S, Wang J, Arima H, Neal B, White DP, Grunstein RR, Zhong N, Anderson CS; SAVE Investigators and Coordinators. CPAP for Prevention of Cardiovascular Events in Obstructive Sleep Apnea. N Engl J Med. 2016 Sep 8;375(10):919-31. doi: 10.1056/NEJMoa1606599. Epub 2016 Aug 28.
- Azarbarzin A, Sands SA, Younes M, Taranto-Montemurro L, Sofer T, Vena D, Alex RM, Kim SW, Gottlieb DJ, White DP, Redline S, Wellman A. The Sleep Apnea-Specific Pulse-Rate Response Predicts Cardiovascular Morbidity and Mortality. Am J Respir Crit Care Med. 2021 Jun 15;203(12):1546-1555. doi: 10.1164/rccm.202010-3900OC.
- Solelhac G, Sanchez-de-la-Torre M, Blanchard M, Berger M, Hirotsu C, Imler T, Sanchez-de-la-Torre A, Haba-Rubio J, Marchi NA, Bayon V, Bailly S, Goupil F, Waeber A, Heiniger G, Pigeanne T, Gracia-Lavedan E, Zapater A, Abad J, Ordax E, Masdeu MJ, Cabriada-Nuno V, Egea C, Van Den Broecke S, Vollenweider P, Marques-Vidal P, Vaucher J, Bernardi G, Betta M, Siclari F, Barbe F, Gagnadoux F, Heinzer R. Pulse Wave Amplitude Drops Index: A Biomarker of Cardiovascular Risk in Obstructive Sleep Apnea. Am J Respir Crit Care Med. 2023 Jun 15;207(12):1620-1632. doi: 10.1164/rccm.202206-1223OC.
- Azarbarzin A, Sands SA, Stone KL, Taranto-Montemurro L, Messineo L, Terrill PI, Ancoli-Israel S, Ensrud K, Purcell S, White DP, Redline S, Wellman A. The hypoxic burden of sleep apnoea predicts cardiovascular disease-related mortality: the Osteoporotic Fractures in Men Study and the Sleep Heart Health Study. Eur Heart J. 2019 Apr 7;40(14):1149-1157. doi: 10.1093/eurheartj/ehy624.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
18 de febrero de 2026
Finalización primaria (Estimado)
31 de diciembre de 2026
Finalización del estudio (Estimado)
30 de septiembre de 2027
Fechas de registro del estudio
Enviado por primera vez
10 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
26 de agosto de 2026
Publicado por primera vez (Actual)
28 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
26 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Nervioso
- 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
- Terapéutica
- Gestión de las vías respiratorias
- Terapia respiratoria
- Respiración de presión positiva
- Respiración, artificial
- Presión positiva continua de las vías respiratorias
Otros números de identificación del estudio
- BIOSA
- 2025-A01061-48 (Otro identificador: French National Agency for the Safety of Medicines and Health Products (ANSM))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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