Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07603583
Acronym
HRV-OSA-HTN
Enrollment
100
Registered
2026-05-22
Start date
2026-04-30
Completion date
2026-12-31
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Obstructive Sleep Apnea

Keywords

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

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.

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.

Interventions

DIAGNOSTIC_TESTPolysomnography

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

Sponsors

Kaohsiung Armed Forces General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Prediction of OSA Severity Using Heart Rate VariabilityBaseline (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

MeasureTime frameDescription
Change in Heart Rate Variability After TreatmentUp to 12 monthsTo assess changes in HRV parameters in patients diagnosed with OSA after receiving standard treatment such as CPAP.

Countries

Taiwan

Contacts

CONTACTYung Kuo Lee, PhD
abstyle0204@gmail.com+886910977485
CONTACTChih-Hsuan Chang, MS
abstyle0204@gmail.com+886905163699
PRINCIPAL_INVESTIGATORYung Kuo Lee, PhD

Kaohsiung Armed Forces General Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026