- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07603583
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Yung Kuo Lee, PhD
- Telefonnummer: +886910977485
- E-mail: abstyle0204@gmail.com
Undersøgelse Kontakt Backup
- Navn: Chih-Hsuan Chang, MS
- Telefonnummer: +886905163699
- E-mail: abstyle0204@gmail.com
Studiesteder
-
-
Kaohsiung
-
Kaohsiung City, Kaohsiung, Taiwan
- Rekruttering
- Kaohsiung Armed Forces General Hospital
-
Kontakt:
- Chih-Hsuan Chang, MS
- Telefonnummer: +886905163699
- E-mail: abstyle0204@gmail.com
-
Kontakt:
- Yung Kuo Lee, PhD
- Telefonnummer: +886910977485
- E-mail: yungkuolee@gmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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.
|
Overnight polysomnography (PSG) will be performed to evaluate sleep parameters and determine the severity of obstructive sleep apnea.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Prediction of OSA Severity Using Heart Rate Variability
Tidsramme: 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).
|
Baseline (at time of HRV monitoring and polysomnography)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Heart Rate Variability After Treatment
Tidsramme: Up to 12 months
|
To assess changes in HRV parameters in patients diagnosed with OSA after receiving standard treatment such as CPAP.
|
Up to 12 months
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Blood Pressure Control After Treatment
Tidsramme: Up to 12 months
|
To evaluate changes in blood pressure levels in patients with OSA after treatment.
|
Up to 12 months
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Yung Kuo Lee, PhD, Kaohsiung Armed Forces General Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i nervesystemet
- Karsygdomme
- Hjerte-kar-sygdomme
- Luftvejssygdomme
- Respirationsforstyrrelser
- Søvnvågningsforstyrrelser
- Apnø
- Søvnforstyrrelser, iboende
- Dyssomnier
- Søvnapnø syndromer
- Forhøjet blodtryk
- Søvnapnø, obstruktiv
- Diagnostiske teknikker og procedurer
- Diagnose
- Overvågning, fysiologisk
- Polysomnografi
Andre undersøgelses-id-numre
- KAFGHIRB 114-092
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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