- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Yung Kuo Lee, PhD
- Número de teléfono: +886910977485
- Correo electrónico: abstyle0204@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Chih-Hsuan Chang, MS
- Número de teléfono: +886905163699
- Correo electrónico: abstyle0204@gmail.com
Ubicaciones de estudio
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Kaohsiung
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Kaohsiung City, Kaohsiung, Taiwán
- Reclutamiento
- Kaohsiung Armed Forces General Hospital
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Contacto:
- Chih-Hsuan Chang, MS
- Número de teléfono: +886905163699
- Correo electrónico: abstyle0204@gmail.com
-
Contacto:
- Yung Kuo Lee, PhD
- Número de teléfono: +886910977485
- Correo electrónico: yungkuolee@gmail.com
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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.
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Overnight polysomnography (PSG) will be performed to evaluate sleep parameters and determine the severity of obstructive sleep apnea.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Prediction of OSA Severity Using Heart Rate Variability
Periodo de tiempo: Baseline (at time of HRV monitoring and polysomnography)
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To evaluate the association between heart rate variability (HRV) parameters and obstructive sleep apnea (OSA) severity as measured by the apnea-hypopnea index (AHI).
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Baseline (at time of HRV monitoring and polysomnography)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Heart Rate Variability After Treatment
Periodo de tiempo: Up to 12 months
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To assess changes in HRV parameters in patients diagnosed with OSA after receiving standard treatment such as CPAP.
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Up to 12 months
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Blood Pressure Control After Treatment
Periodo de tiempo: Up to 12 months
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To evaluate changes in blood pressure levels in patients with OSA after treatment.
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Up to 12 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Yung Kuo Lee, PhD, Kaohsiung Armed Forces General Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Nervioso
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Enfermedades de las vías respiratorias
- Trastornos de la respiración
- Trastornos del sueño y la vigilia
- Apnea
- Trastornos del Sueño Intrínsecos
- Disomnias
- Síndromes de apnea del sueño
- Hipertensión
- Apnea del Sueño Obstructiva
- Técnicas y procedimientos de diagnóstico
- Diagnóstico
- Monitoreo, fisiológico
- Polisomnografía
Otros números de identificación del estudio
- KAFGHIRB 114-092
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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