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临床试验/NCT07531992
NCT07531992尚未招募不适用

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

Sinop University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
RMSSD Across Different Analysis Durations

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Healthy Adult Assessment Group

Experimental

Healthy adult participants will attend a single study visit and undergo resting hemodynamic and heart rate variability (HRV) assessment under standardized conditions. After an adaptation period, systolic blood pressure, diastolic blood pressure, and pulse will be measured using an automated oscillometric blood pressure monitor. A continuous RR interval recording will then be obtained using the Polar H10 chest strap. HRV parameters will be derived from predefined 1-minute, 5-minute, 10-minute, and 20-minute analysis windows extracted from the same recording for methodological comparison.

干预措施: Heart Rate Variability and Blood Pressure Assessment (Other)

结局指标

主要结局

RMSSD Across Different Analysis Durations

时间窗: Baseline, during a single study visit

Root mean square of successive differences (RMSSD), in milliseconds (ms), calculated from predefined 1-minute, 5-minute, 10-minute, and 20-minute analysis windows extracted from the same continuous resting RR interval recording obtained under standardized resting conditions.

SDNN Across Different Analysis Durations

时间窗: Baseline, during a single study visit

Standard deviation of normal-to-normal intervals (SDNN), in milliseconds (ms), calculated from predefined 1-minute, 5-minute, 10-minute, and 20-minute analysis windows extracted from the same continuous resting RR interval recording obtained under standardized resting conditions.

Low-Frequency Power Across Different Analysis Durations

时间窗: Baseline, during a single study visit

Low-frequency (LF) power, in ms\^2, calculated from predefined 1-minute, 5-minute, 10-minute, and 20-minute analysis windows extracted from the same continuous resting RR interval recording obtained under standardized resting conditions.

High-Frequency Power Across Different Analysis Durations

时间窗: Baseline, during a single study visit.

High-frequency (HF) power, in ms\^2, calculated from predefined 1-minute, 5-minute, 10-minute, and 20-minute analysis windows extracted from the same continuous resting RR interval recording obtained under standardized resting conditions.

LF/HF Ratio Across Different Analysis Durations

时间窗: Baseline, during a single study visit.

Low-frequency/high-frequency (LF/HF) ratio calculated from predefined 1-minute, 5-minute, 10-minute, and 20-minute analysis windows extracted from the same continuous resting RR interval recording obtained under standardized resting conditions.

次要结局

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

研究者

发起方
Sinop University
申办方类型
Other
责任方
Principal Investigator
主要研究者

SEFA HAKTAN HATIK

Assistant professor

Sinop University

研究点 (1)

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