Assessment of Heart Rate Variability for Predicting Obstructive Sleep Apnea in Patients With Hypertension (HRV-OSA-HTN)
The Exploration of the Relationship Between Hypertension and Sleep Apnea Through Heart Rate Variability, and the Subsequent Investigation of Non-pharmacological and Pharmacological Treatments
This study aims to investigate the relationship between hypertension and obstructive sleep apnea (OSA) using heart rate variability (HRV) as a non-invasive biomarker of autonomic nervous system function.
Hypertensive patients at high risk for OSA will undergo 24-hour Holter electrocardiogram monitoring to assess HRV parameters, along with overnight polysomnography (PSG) to determine OSA severity. The study will analyze the association between HRV indices and the apnea-hypopnea index (AHI), and develop predictive models using machine learning techniques.
In addition, patients diagnosed with OSA will be followed after treatment, and changes in HRV and blood pressure will be evaluated to assess treatment effects and autonomic function recovery.
The results of this study may provide a cost-effective and clinically applicable approach for early detection, risk stratification, and management of OSA in patients with hypertension.
研究概览
详细说明
This study is designed as a prospective observational cohort study to investigate the association between heart rate variability (HRV), hypertension, and obstructive sleep apnea (OSA).
Participants will be recruited from outpatient clinics and include adult patients aged 18 to 65 years with diagnosed hypertension or resistant hypertension and a STOP-Bang score ≥3. After providing informed consent, eligible participants will undergo 24-hour ambulatory electrocardiogram monitoring using a Holter device to obtain HRV parameters, including time-domain indices (e.g., SDNN, RMSSD) and frequency-domain indices (e.g., LF, HF, VLF, and LF/HF ratio). In parallel, overnight polysomnography (PSG) will be performed to determine sleep parameters and OSA severity based on the apnea-hypopnea index (AHI).
Clinical data, including demographic characteristics, blood pressure measurements, and relevant laboratory results, will also be collected. Statistical analyses will include descriptive statistics, correlation analysis, and regression modeling to evaluate the relationship between HRV parameters and OSA severity.
Machine learning approaches will be applied to develop predictive models for OSA severity using HRV features. Algorithms such as linear regression, support vector machines, random forest, and gradient boosting methods will be evaluated. Model performance will be assessed using metrics including mean squared error (MSE), mean absolute error (MAE), and coefficient of determination (R²), with cross-validation techniques to ensure robustness.
In a subsequent phase, participants diagnosed with OSA and receiving standard treatment (e.g., continuous positive airway pressure, CPAP) will be followed longitudinally. Changes in HRV parameters and blood pressure profiles will be analyzed to assess autonomic nervous system recovery and treatment response.
This study aims to establish a non-invasive, clinically applicable, and cost-effective strategy for screening and risk stratification of OSA in patients with hypertension, with potential applications in telemedicine and wearable health monitoring systems.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Yung Kuo Lee, PhD
- 电话号码:+886910977485
- 邮箱:abstyle0204@gmail.com
研究联系人备份
- 姓名:Chih-Hsuan Chang, MS
- 电话号码:+886905163699
- 邮箱:abstyle0204@gmail.com
学习地点
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Kaohsiung
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Kaohsiung City、Kaohsiung、台湾
- 招聘中
- Kaohsiung Armed Forces General Hospital
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接触:
- Chih-Hsuan Chang, MS
- 电话号码:+886905163699
- 邮箱:abstyle0204@gmail.com
-
接触:
- Yung Kuo Lee, PhD
- 电话号码:+886910977485
- 邮箱:yungkuolee@gmail.com
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- Age 18 to 65 years
- Diagnosed hypertension or resistant hypertension
- STOP-Bang score ≥3 indicating high risk of obstructive sleep apnea
- Willing and able to provide informed consent
Exclusion Criteria:
- Refusal to undergo HRV monitoring or polysomnography
- Unstable medical condition that may interfere with study participation
- Inability to comply with study procedures
学习计划
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 |
|---|---|
|
Hypertensive Patients With Suspected OSA
Adult patients aged 18 to 65 years with diagnosed hypertension or resistant hypertension and high risk of obstructive sleep apnea (STOP-Bang score ≥3).
Participants will undergo 24-hour Holter monitoring for heart rate variability (HRV) assessment and overnight polysomnography (PSG) to evaluate sleep parameters and OSA severity.
Clinical data including blood pressure and relevant medical history will be collected for analysis.
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Overnight polysomnography (PSG) will be performed to evaluate sleep parameters and determine the severity of obstructive sleep apnea.
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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 |
|---|---|---|
|
Prediction of OSA Severity Using Heart Rate Variability
大体时间:Baseline (at time of HRV monitoring and polysomnography)
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To evaluate the association between heart rate variability (HRV) parameters and obstructive sleep apnea (OSA) severity as measured by the apnea-hypopnea index (AHI).
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Baseline (at time of HRV monitoring and polysomnography)
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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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Change in Heart Rate Variability After Treatment
大体时间:Up to 12 months
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To assess changes in HRV parameters in patients diagnosed with OSA after receiving standard treatment such as CPAP.
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Up to 12 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Blood Pressure Control After Treatment
大体时间:Up to 12 months
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To evaluate changes in blood pressure levels in patients with OSA after treatment.
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Up to 12 months
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合作者和调查者
调查人员
- 首席研究员:Yung Kuo Lee, PhD、Kaohsiung Armed Forces General Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- KAFGHIRB 114-092
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
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研究美国 FDA 监管的设备产品
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