An observational study in Obstructive Sleep Apnea and Hypertension, sponsored by Kaohsiung Armed Forces General Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Kaohsiung Armed Forces General Hospital · Observational
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.
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.
2,198 studies on the registry are indexed under Sleep Apnea, Obstructive; 469 are open to participants now.
This study's planned enrollment of 100 is close to the median of 104 across 648 observational studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Kaohsiung Armed Forces General Hospital is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients aged 18 to 65 years with diagnosed hypertension or resistant hypertension who are at high risk for obstructive sleep apnea will be recruited from outpatient clinics. Participants will undergo heart rate variability monitoring and polysomnography for evaluation.
Exclusion Criteria:
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.
Diagnostic Test: Polysomnography
Overnight polysomnography (PSG) will be performed to evaluate sleep parameters and determine the severity of obstructive sleep apnea.
Prediction of OSA Severity Using Heart Rate Variability
To evaluate the association between heart rate variability (HRV) parameters and obstructive sleep apnea (OSA) severity as measured by the apnea-hypopnea index (AHI).
Time frame: Baseline (at time of HRV monitoring and polysomnography)
Change in Heart Rate Variability After Treatment
To assess changes in HRV parameters in patients diagnosed with OSA after receiving standard treatment such as CPAP.
Time frame: Up to 12 months
Blood Pressure Control After Treatment
To evaluate changes in blood pressure levels in patients with OSA after treatment.
Time frame: Up to 12 months
Plan to share: No — Individual participant data (IPD) will not be shared due to privacy and confidentiality considerations. The collected data contain sensitive clinical information, and sharing of individual-level data is not included in the current study design or approved by the institutional review board (IRB).
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Kaohsiung Armed Forces General Hospital