Assessment of Heart Rate Variability for Predicting Obstructive Sleep Apnea in Patients With Hypertension

NCT07603583 | Recruiting

• 1 other identifier: KAFGHIRB 114-092
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea; Hypertension

Keywords

Heart Rate Variability; Polysomnography; CPAP; Sleep Apnea Screening; Machine Learning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Heart Rate Variability After Treatment

  Up to 12 months

Other Outcomes (1)

• Blood Pressure Control After Treatment

  Up to 12 months

Study Arms (1)

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

Interventions

Polysomnography DIAGNOSTIC_TEST

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

Hypertensive Patients With Suspected OSA

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Refusal to undergo HRV monitoring or polysomnography
• Unstable medical condition that may interfere with study participation
• Inability to comply with study procedures

Sponsors & Collaborators

• Kaohsiung Armed Forces General Hospital: lead

Study Sites (1)

Kaohsiung Armed Forces General Hospital

Kaohsiung City, Kaohsiung, Taiwan

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Hypertension

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Yung Kuo Lee, PhD

  Kaohsiung Armed Forces General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yung Kuo Lee, PhD

CONTACT

+886910977485; abstyle0204@gmail.com

Chih-Hsuan Chang, MS

CONTACT

+886905163699; abstyle0204@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 22, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)