- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07531992
Comparison of Heart Rate Variability Analysis Durations and Their Relationship With Blood Pressure (HRV-BP)
Comparison of Heart Rate Variability Analysis Durations and Their Relationship With Blood Pressure: A Methodological Comparative Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sefa Haktan Hatık, PhD
- Phone Number: +90 368 271 55 28
- Email: haktanhtk@gmail.com
Study Locations
-
-
-
Artvin, Turkey (Türkiye)
- Artvin Coruh University, Artvin Vocational School, Disabled Care and Rehabilitation Laboratory, Artvin,
-
Contact:
- Ömer Dicle Kızıl, MSc
- Phone Number: +90 541 523 36 91
- Email: omerdiclekizil@gmail.com
-
Sub-Investigator:
- Ömer Dicle Kızıl, MSc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Healthy Adult Assessment Group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
RMSSD Across Different Analysis Durations
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.
|
Baseline, during a single study visit
|
|
SDNN Across Different Analysis Durations
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.
|
Baseline, during a single study visit
|
|
Low-Frequency Power Across Different Analysis Durations
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.
|
Baseline, during a single study visit
|
|
High-Frequency Power Across Different Analysis Durations
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.
|
Baseline, during a single study visit.
|
|
LF/HF Ratio Across Different Analysis Durations
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.
|
Baseline, during a single study visit.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Agreement of RMSSD Across Different Analysis Durations
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.
|
Baseline, during a single study visit
|
|
Agreement of SDNN Across Different Analysis Durations
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.
|
Baseline, during a single study visit
|
|
Agreement of Low-Frequency Power Across Different Analysis Durations
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.
|
Baseline, during a single study visit
|
|
Agreement of High-Frequency Power Across Different Analysis Durations
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.
|
Baseline, during a single study visit
|
|
Agreement of LF/HF Ratio Across Different Analysis Durations
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.
|
Baseline, during a single study visit
|
|
Correlation Between RMSSD and Resting Systolic Blood Pressure
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.
|
Baseline, during a single study visit
|
|
Correlation Between RMSSD and Resting Diastolic Blood Pressure
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.
|
Baseline, during a single study visit
|
|
Correlation Between RMSSD and Mean Arterial Pressure
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.
|
Baseline, during a single study visit
|
|
Resting Systolic Blood Pressure
Time Frame: Baseline, during a single study visit
|
Resting systolic blood pressure, in mmHg, measured under standardized resting conditions before HRV recording.
|
Baseline, during a single study visit
|
|
Resting Diastolic Blood Pressure
Time Frame: Baseline, during a single study visit
|
Resting diastolic blood pressure, in mmHg, measured under standardized resting conditions before HRV recording.
|
Baseline, during a single study visit
|
|
Mean Arterial Pressure
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.
|
Baseline, during a single study visit
|
|
Resting Pulse Rate
Time Frame: Baseline, during a single study visit
|
Resting pulse rate, in beats per minute, measured under standardized resting conditions before HRV recording.
|
Baseline, during a single study visit
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- TAVNS7
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heart Rate Variability
-
University of Southern CaliforniaTerminated
-
National Taiwan University HospitalUnknownHeart Rate VariabilityTaiwan
-
University of California, IrvineNational Institute on Minority Health and Health Disparities (NIMHD); Emory...Completed
-
Université du Québec a MontréalCollège d'Études Ostéopathiques de MontrealCompletedHeart Rate VariabilityCanada
-
Imam Abdulrahman Bin Faisal UniversityCompletedHeart Rate VariabilitySaudi Arabia
-
Florida State UniversityCompletedHeart Rate Variability | Appetite | Resting Metabolic RateUnited States
-
Inonu UniversityCompletedHeart Rate Variability | SportTurkey
-
PepsiCo Global R&DRecruitingHeart Rate VariabilityUnited States
-
University of Sao PauloUnknownHeart Rate VariabilityBrazil
-
Kaohsiung Medical UniversityCompleted
Clinical Trials on Heart Rate Variability and Blood Pressure Assessment
-
Hippocration General HospitalKAT General Hospital; Sismanoglio General Hospital; Thriasio General Hospital; Elpis... and other collaboratorsRecruitingMyocardial Infarction With Nonobstructive Coronary ArteriesGreece
-
University of Roma La SapienzaUnknownClinical and Geriatric Assessment in Elderly Patients Before and After TAVI or MitraClip PositioningMitral Valve Insufficiency | Aortic Stenosis SenileItaly
-
University of California, San DiegoUnknown
-
Centre Hospitalier Universitaire de NīmesRecruitingSurgery--ComplicationsFrance
-
University Hospital Bispebjerg and FrederiksbergRecruitingHeart FailureDenmark
-
University of Sao PauloActive, not recruitingReliability and ValidityBrazil
-
University of IowaCompletedAcute Coronary SyndromeUnited States
-
University of ParmaAzienda Ospedaliero-Universitaria di ParmaRecruitingMild Birth Asphyxia | Moderate Birth AsphyxiaItaly
-
Karolinska University HospitalKarolinska InstitutetCompletedNeuroinflammationSweden
-
University of Southern CaliforniaNational Institute of Mental Health (NIMH)Recruiting