Sleep Apnea Biomarkers and Adherence to Continuous Positive Airway Pressure (BIOSA)
2026年8月26日 更新者：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.
研究概览
详细说明
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.
研究类型
观察性的
注册 (估计的)
200
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Francois FB Bughin, MD, PhD
- 电话号码：0033761783081
- 邮箱：fbughin@hotmail.com
学习地点
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Montpellier、法国、34000
- 招聘中
- Clinique Millenaire
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接触：
- Francois FB Bughin, Study Principal Investigator
- 电话号码：0033761783081
- 邮箱：fbughin@hotmail.com
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
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.
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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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.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Association Between Baseline Hypoxic Burden and CPAP Adherence at 3 Months
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Distribution of Baseline Sleep Apnea Biomarkers
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年2月18日
初级完成 (估计的)
2026年12月31日
研究完成 (估计的)
2027年9月30日
研究注册日期
首次提交
2026年8月10日
首先提交符合 QC 标准的
2026年8月26日
首次发布 (实际的)
2026年8月28日
研究记录更新
最后更新发布 (实际的)
2026年8月28日
上次提交的符合 QC 标准的更新
2026年8月26日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- BIOSA
- 2025-A01061-48 (其他标识符：French National Agency for the Safety of Medicines and Health Products (ANSM))
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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