Comparison of Heart Rate Variability Analysis Durations and Their Relationship With Blood Pressure

Официальное название

Comparison of Heart Rate Variability Analysis Durations and Their Relationship With Blood Pressure: A Methodological Comparative Study

Обзор

This observational study aims to compare heart rate variability (HRV) parameters obtained from different analysis durations in healthy adults and to examine how these parameters relate to resting blood pressure values. HRV is a noninvasive measure commonly used to assess autonomic nervous system activity. Standard short-term HRV analysis is typically based on 5-minute recordings, but shorter and longer analysis durations are also used in research and practice. This study will evaluate whether HRV values derived from 1-minute, 5-minute, 10-minute, and 20-minute analysis windows differ from one another and whether their relationships with systolic blood pressure, diastolic blood pressure, and mean arterial pressure change according to analysis duration. Participants will attend a single study visit. After a rest period, resting blood pressure and pulse will be measured, and a continuous HRV recording will be obtained using a chest strap device. The study is designed to provide methodological information on the comparability of different HRV analysis durations under the same physiological conditions.

Подробное описание

Heart rate variability (HRV) is widely used as a noninvasive indicator of autonomic nervous system regulation and provides information about sympathetic-parasympathetic balance. Although 5-minute recordings are commonly recommended for short-term HRV assessment, interest has increased in ultra-short and longer analysis durations because they may improve feasibility and reduce participant burden. However, the extent to which HRV parameters derived from different analysis durations agree with one another remains uncertain, particularly when comparing time-domain and frequency-domain measures. In addition, limited research has systematically examined whether the relationship between HRV and blood pressure varies according to HRV analysis duration. This study is intended to address that methodological gap.

This is a single-center, single-visit, observational methodological comparison study in healthy adults. Eligible participants will complete a sociodemographic data form and will undergo resting hemodynamic assessment and HRV recording under standardized conditions. Measurements will be performed in a quiet environment after an adaptation period. Resting systolic blood pressure, diastolic blood pressure, and pulse will be measured using an automated oscillometric upper-arm blood pressure monitor. RR interval data will then be recorded continuously using the Polar H10 chest strap and analyzed using Kubios HRV software.

HRV analyses will be derived from a single continuous recording using predefined analysis windows of 1 minute, 5 minutes, 10 minutes, and 20 minutes. These windows will be extracted from the same physiological recording in order to minimize time-related variation and allow direct comparison across durations. Time-domain and frequency-domain HRV parameters will be calculated, and the agreement and comparability of measurements across analysis durations will be evaluated. Associations between HRV parameters and resting hemodynamic variables, including systolic blood pressure, diastolic blood pressure, mean arterial pressure, and pulse, will also be examined according to analysis duration.

The study is expected to provide methodological evidence regarding whether shorter or longer HRV analysis durations can be interpreted consistently relative to standard short-term recordings. The findings may help improve protocol standardization and support more accurate physiological and clinical interpretation of HRV data obtained under resting conditions.

Вмешательства

• Другое Heart Rate Variability and Blood Pressure Assessment
  Participants will complete a single-visit resting physiological assessment under standardized conditions. After an adaptation period, systolic blood pressure, diastolic blood pressure, and pulse will be measured using an automated oscillometric upper-arm blood pressure monitor. Continuous RR interval data will then be recorded using the Polar H10 chest strap and analyzed with Kubios HRV software. Heart rate variability parameters will be calculated from predefined 1-minute, 5-minute, 10-minute,

Первичные конечные точки

• RMSSD Across Different Analysis Durations [Срок оценки: Baseline, during a single study visit]
• SDNN Across Different Analysis Durations [Срок оценки: Baseline, during a single study visit]
• Low-Frequency Power Across Different Analysis Durations [Срок оценки: Baseline, during a single study visit]
• High-Frequency Power Across Different Analysis Durations [Срок оценки: Baseline, during a single study visit.]
• LF/HF Ratio Across Different Analysis Durations [Срок оценки: Baseline, during a single study visit.]

Вторичные конечные точки (12)

• Agreement of RMSSD Across Different Analysis Durations [Срок оценки: Baseline, during a single study visit]
• Agreement of SDNN Across Different Analysis Durations [Срок оценки: Baseline, during a single study visit]
• Agreement of Low-Frequency Power Across Different Analysis Durations [Срок оценки: Baseline, during a single study visit]
• Agreement of High-Frequency Power Across Different Analysis Durations [Срок оценки: Baseline, during a single study visit]
• Agreement of LF/HF Ratio Across Different Analysis Durations [Срок оценки: Baseline, during a single study visit]
• Correlation Between RMSSD and Resting Systolic Blood Pressure [Срок оценки: Baseline, during a single study visit]
• Correlation Between RMSSD and Resting Diastolic Blood Pressure [Срок оценки: Baseline, during a single study visit]
• Correlation Between RMSSD and Mean Arterial Pressure [Срок оценки: Baseline, during a single study visit]
• Resting Systolic Blood Pressure [Срок оценки: Baseline, during a single study visit]
• Resting Diastolic Blood Pressure [Срок оценки: Baseline, during a single study visit]
• Mean Arterial Pressure [Срок оценки: Baseline, during a single study visit]
• Resting Pulse Rate [Срок оценки: Baseline, during a single study visit]

Критерии участия

Критерии включения

• Healthy adults aged 18 to 40 years
• Willing and able to provide informed consent
• Able to comply with pre-assessment instructions, including restrictions related to caffeine intake and strenuous physical activity
• No condition preventing heart rate variability and blood pressure measurements

Критерии исключения

• History of diagnosed cardiovascular, neurological, or autonomic nervous system disease
• Known arrhythmia or pacemaker use
• Regular use of medications that may affect heart rate variability, such as beta blockers or antiarrhythmic drugs
• Acute infection, fever, or any condition affecting general health status on the day of assessment
• Severe motion artifact during measurement or technically unusable recordings

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Turkey (Türkiye) · 1 центр

• Artvin Coruh University, Artvin Vocational School, Disabled Care and Rehabilitation Labora — Artvin

Публикации

• Munoz ML, van Roon A, Riese H, Thio C, Oostenbroek E, Westrik I, de Geus EJ, Gansevoort R, Lefrandt J, Nolte IM, Snieder H. Validity of (Ultra-)Short Recordings for Heart Rate Variability Measurements. PLoS One. 2015 Sep 28;10(9):e0138921. doi: 10.1371/journal.pone.0138921. eCollection 2015. PMID 26414314
• Thayer JF, Yamamoto SS, Brosschot JF. The relationship of autonomic imbalance, heart rate variability and cardiovascular disease risk factors. Int J Cardiol. 2010 May 28;141(2):122-31. doi: 10.1016/j.ijcard.2009.09.543. Epub 2009 Nov 11. PMID 19910061
• Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available. PMID 8598068
• Shaffer F, Ginsberg JP. An Overview of Heart Rate Variability Metrics and Norms. Front Public Health. 2017 Sep 28;5:258. doi: 10.3389/fpubh.2017.00258. eCollection 2017. PMID 29034226

Идентификаторы

NCT: NCT07531992 · TAVNS7

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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