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NCT Number: NCT07603583

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polysomnography

Diagnostic Test

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

Primary outcomes

  1. Prediction of OSA Severity Using Heart Rate Variability

    Time frame: Baseline (at time of HRV monitoring and polysomnography)

    To evaluate the association between heart rate variability (HRV) parameters and obstructive sleep apnea (OSA) severity as measured by the apnea-hypopnea index (AHI).

Secondary outcomes

  1. Change in Heart Rate Variability After Treatment

    Time frame: Up to 12 months

    To assess changes in HRV parameters in patients diagnosed with OSA after receiving standard treatment such as CPAP.

Other outcomes

  1. Blood Pressure Control After Treatment

    Time frame: Up to 12 months

    To evaluate changes in blood pressure levels in patients with OSA after treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Chih-Hsuan Chang, MS

CONTACT

[email protected]

+886905163699

Yung Kuo Lee, PhD

CONTACT

[email protected]

+886910977485

Sponsors and collaborators

Lead sponsor

Kaohsiung Armed Forces General Hospital

Other

Registry information

Official study title

The Exploration of the Relationship Between Hypertension and Sleep Apnea Through Heart Rate Variability, and the Subsequent Investigation of Non-pharmacological and Pharmacological Treatments

Acronym: HRV-OSA-HTN

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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