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Heart Rate VariabilityHRV-BPNCT07531992

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

A study testing Heart Rate Variability and Blood Pressure Assessment in people with Heart Rate Variability, run by Sinop University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Heart Rate Variability
What is being tested?
Heart Rate Variability and Blood Pressure Assessment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 May 2026to 15 Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sefa Haktan Hatık, PhD contact

+90 368 271 55 28

haktanhtk@gmail.com

Turkey (Türkiye)1 site
  • Artvin Coruh University, Artvin Vocational School, Disabled Care and Rehabilitation Laboratory, Artvin,

    Artvin

    Ömer Dicle Kızıl, MSc, +90 541 523 36 91, omerdiclekizil@gmail.com

    Ömer Dicle Kızıl, MSc

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Being tested
Heart Rate Variability and Blood Pressure Assessment
Keywords
Heart Rate Variability, HRV, Autonomic Nervous System

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Heart Rate Variability and Blood Pressure AssessmentOther

    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.

Study groups in NCT07531992
Study groupRoleWhat they receive
Healthy Adult Assessment GroupExperimentalHealthy 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.
Receives: Other: Heart Rate Variability and Blood Pressure Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. RMSSD Across Different Analysis Durations

    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.

    Measured: Baseline, during a single study visit

  2. SDNN Across Different Analysis Durations

    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.

    Measured: Baseline, during a single study visit

  3. Low-Frequency Power Across Different Analysis Durations

    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.

    Measured: Baseline, during a single study visit

  4. High-Frequency Power Across Different Analysis Durations

    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.

    Measured: Baseline, during a single study visit.

  5. LF/HF Ratio Across Different Analysis Durations

    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.

    Measured: Baseline, during a single study visit.

Secondary outcomes (12)
  1. Agreement of RMSSD Across Different Analysis Durations

    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.

    Measured: Baseline, during a single study visit

  2. Agreement of SDNN Across Different Analysis Durations

    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.

    Measured: Baseline, during a single study visit

  3. Agreement of Low-Frequency Power Across Different Analysis Durations

    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.

    Measured: Baseline, during a single study visit

  4. Agreement of High-Frequency Power Across Different Analysis Durations

    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.

    Measured: Baseline, during a single study visit

  5. Agreement of LF/HF Ratio Across Different Analysis Durations

    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.

    Measured: Baseline, during a single study visit

  6. Correlation Between RMSSD and Resting Systolic Blood Pressure

    Correlation between RMSSD, in milliseconds (ms), and resting systolic blood pressure, in mmHg, measured under standardized resting conditions during the same study visit.

    Measured: Baseline, during a single study visit

  7. Correlation Between RMSSD and Resting Diastolic Blood Pressure

    Correlation between RMSSD, in milliseconds (ms), and resting diastolic blood pressure, in mmHg, measured under standardized resting conditions during the same study visit.

    Measured: Baseline, during a single study visit

  8. Correlation Between RMSSD and Mean Arterial Pressure

    Correlation between RMSSD, in milliseconds (ms), and mean arterial pressure, in mmHg, calculated from resting blood pressure measurements obtained during the same study visit.

    Measured: Baseline, during a single study visit

  9. Resting Systolic Blood Pressure

    Resting systolic blood pressure, in mmHg, measured under standardized resting conditions before HRV recording.

    Measured: Baseline, during a single study visit

  10. Resting Diastolic Blood Pressure

    Resting diastolic blood pressure, in mmHg, measured under standardized resting conditions before HRV recording.

    Measured: Baseline, during a single study visit

  11. Mean Arterial Pressure

    Mean arterial pressure, in mmHg, calculated from resting systolic and diastolic blood pressure measurements obtained under standardized resting conditions before HRV recording.

    Measured: Baseline, during a single study visit

  12. Resting Pulse Rate

    Resting pulse rate, in beats per minute, measured under standardized resting conditions before HRV recording.

    Measured: Baseline, during a single study visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2026
  2. Study start1 May 2026 (estimated)
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion15 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07531992
Sponsor's protocol ID
TAVNS7
Acronym
HRV-BP
Status last verified
Apr 2026
First submitted
6 Apr 2026
Last updated
15 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 29034226

Questions about this trial

What is this clinical trial studying?

A study testing Heart Rate Variability and Blood Pressure Assessment in people with Heart Rate Variability, run by Sinop University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sefa Haktan Hatık, PhD (+90 368 271 55 28, haktanhtk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RMSSD Across Different Analysis Durations (time frame: Baseline, during a single study visit). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07531992, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.

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