Artvin Coruh University, Artvin Vocational School, Disabled Care and Rehabilitation Laboratory, Artvin,
Artvin, Turkey (Türkiye)
Location contact
Ömer Dicle Kızıl, MSc
CONTACT
Ömer Dicle Kızıl, MSc
SUB_INVESTIGATOR
NCT Number: NCT07531992
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.
Trial opening soon.
Get Notified18 year–40 year
All sexes
Interventional
Not applicable
Artvin, Turkey (Türkiye)
Ömer Dicle Kızıl, MSc
CONTACT
Ömer Dicle Kızıl, MSc
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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, and 20-minute analysis windows extracted from the same continuous recording for methodological comparison.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, during a single study visit
Agreement of RMSSD values, in milliseconds (ms), obtained from 1-minute, 5-minute, 10-minute, and 20-minute analysis windows extracted from the same continuous resting RR interval recording, assessed using intraclass correlation coefficients and Bland-Altman analysis.
Time frame: Baseline, during a single study visit
Agreement of SDNN values, in milliseconds (ms), obtained from 1-minute, 5-minute, 10-minute, and 20-minute analysis windows extracted from the same continuous resting RR interval recording, assessed using intraclass correlation coefficients and Bland-Altman analysis.
Time frame: Baseline, during a single study visit
Agreement of low-frequency (LF) power values, in ms^2, obtained from 1-minute, 5-minute, 10-minute, and 20-minute analysis windows extracted from the same continuous resting RR interval recording, assessed using intraclass correlation coefficients and Bland-Altman analysis.
Time frame: Baseline, during a single study visit
Agreement of high-frequency (HF) power values, in ms^2, obtained from 1-minute, 5-minute, 10-minute, and 20-minute analysis windows extracted from the same continuous resting RR interval recording, assessed using intraclass correlation coefficients and Bland-Altman analysis.
Time frame: Baseline, during a single study visit
Agreement of low-frequency/high-frequency (LF/HF) ratio values obtained from 1-minute, 5-minute, 10-minute, and 20-minute analysis windows extracted from the same continuous resting RR interval recording, assessed using intraclass correlation coefficients and Bland-Altman analysis.
Time frame: Baseline, during a single study visit
Correlation between RMSSD, in milliseconds (ms), and resting systolic blood pressure, in mmHg, measured under standardized resting conditions during the same study visit.
Time frame: Baseline, during a single study visit
Correlation between RMSSD, in milliseconds (ms), and resting diastolic blood pressure, in mmHg, measured under standardized resting conditions during the same study visit.
Time frame: Baseline, during a single study visit
Correlation between RMSSD, in milliseconds (ms), and mean arterial pressure, in mmHg, calculated from resting blood pressure measurements obtained during the same study visit.
Time frame: Baseline, during a single study visit
Resting systolic blood pressure, in mmHg, measured under standardized resting conditions before HRV recording.
Time frame: Baseline, during a single study visit
Resting diastolic blood pressure, in mmHg, measured under standardized resting conditions before HRV recording.
Time frame: Baseline, during a single study visit
Mean arterial pressure, in mmHg, calculated from resting systolic and diastolic blood pressure measurements obtained under standardized resting conditions before HRV recording.
Time frame: Baseline, during a single study visit
Resting pulse rate, in beats per minute, measured under standardized resting conditions before HRV recording.
Contact information is provided by the study sponsor or research team.
Sinop University
Other
Comparison of Heart Rate Variability Analysis Durations and Their Relationship With Blood Pressure: A Methodological Comparative Study
Acronym: HRV-BP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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