Assessment of Heart Rate Variability for Predicting Obstructive Sleep Apnea in Patients With Hypertension
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorKaohsiung Armed Forces General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Refusal to undergo HRV monitoring or polysomnography
Unstable medical condition that may interfere with study participation
Inability to comply with study procedures
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Polysomnography
Diagnostic testOvernight polysomnography (PSG) will be performed to evaluate sleep parameters and determine the severity of obstructive sleep apnea.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Hypertensive Patients With Suspected OSA1 intervention
Trial outcomes
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).
Time frame
Baseline (at time of HRV monitoring and polysomnography)Secondary outcomes
1
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 monthsOther outcomes
1
Blood Pressure Control After Treatment
To evaluate changes in blood pressure levels in patients with OSA after treatment.
Time frame
Up to 12 monthsSponsors and contacts
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Source ClinicalTrials.gov