Sleep Apnea Biomarkers and Adherence to Continuous Positive Airway Pressure (BIOSA)
26 августа 2026 г. обновлено: 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.
Обзор исследования
Статус
Рекрутинг
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Наблюдательный
Регистрация (Оцененный)
200
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Francois FB Bughin, MD, PhD
- Номер телефона: 0033761783081
- Электронная почта: fbughin@hotmail.com
Места учебы
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Montpellier, Франция, 34000
- Рекрутинг
- Clinique Millenaire
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Контакт:
- Francois FB Bughin, Study Principal Investigator
- Номер телефона: 0033761783081
- Электронная почта: fbughin@hotmail.com
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Метод выборки
Невероятностная выборка
Исследуемая популяция
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.
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
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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.
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Association Between Baseline Hypoxic Burden and CPAP Adherence at 3 Months
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Distribution of Baseline Sleep Apnea Biomarkers
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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.
|
Baseline and 3 months after CPAP initiation
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- 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.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
18 февраля 2026 г.
Первичное завершение (Оцененный)
31 декабря 2026 г.
Завершение исследования (Оцененный)
30 сентября 2027 г.
Даты регистрации исследования
Первый отправленный
10 августа 2026 г.
Впервые представлено, что соответствует критериям контроля качества
26 августа 2026 г.
Первый опубликованный (Действительный)
28 августа 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
28 августа 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
26 августа 2026 г.
Последняя проверка
1 августа 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Заболевания нервной системы
- Заболевания дыхательных путей
- Нарушения дыхания
- Расстройства сна и бодрствования
- Апноэ
- Расстройства сна, внутренние
- Диссомнии
- Синдромы апноэ во сне
- Апноэ сна, обструктивное
- Терапия
- Управление дыхательными путями
- Респираторная терапия
- Дыхание положительного давления
- Дыхание, искусственное
- Непрерывное положительное давление в дыхательных путях
Другие идентификационные номера исследования
- BIOSA
- 2025-A01061-48 (Другой идентификатор: French National Agency for the Safety of Medicines and Health Products (ANSM))
Планирование данных отдельных участников (IPD)
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НЕ РЕШЕНО
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .