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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension; Obstructive Sleep Apnea
• Intervention / Treatment: Diagnostic test: Polysomnography

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Yung Kuo Lee, PhD; Phone Number: +886910977485; Email: abstyle0204@gmail.com
• Study Contact Backup: Name: Chih-Hsuan Chang, MS; Phone Number: +886905163699; Email: abstyle0204@gmail.com

Study Locations

• Taiwan
  • Kaohsiung
    • Kaohsiung City, Kaohsiung, Taiwan
      • Recruiting
      • Kaohsiung Armed Forces General Hospital
      • Contact: Chih-Hsuan Chang, MS; Phone Number: +886905163699; Email: abstyle0204@gmail.com
      • Contact: Yung Kuo Lee, PhD; Phone Number: +886910977485; Email: yungkuolee@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Diagnostic test: Polysomnography; Overnight polysomnography (PSG) will be performed to evaluate sleep parameters and determine the severity of obstructive sleep apnea.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline (at time of HRV monitoring and polysomnography)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure Control After Treatment	To evaluate changes in blood pressure levels in patients with OSA after treatment.	Up to 12 months

Collaborators and Investigators

• Sponsor: Kaohsiung Armed Forces General Hospital
• Investigators: Principal Investigator: Yung Kuo Lee, PhD, Kaohsiung Armed Forces General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 18, 2026
• First Submitted That Met QC Criteria: May 18, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Heart Rate Variability; Polysomnography; CPAP; Machine Learning; Sleep Apnea Screening
• Additional Relevant MeSH Terms: Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Hypertension; Sleep Apnea, Obstructive; Diagnostic Techniques and Procedures; Diagnosis; Monitoring, Physiologic; Polysomnography
• Other Study ID Numbers: KAFGHIRB 114-092

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No