NCT07531992

Brief 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. 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 Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress33%
May 2026Sep 2026

First Submitted

Initial submission to the registry

April 6, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 15, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2026

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

April 6, 2026

Last Update Submit

April 13, 2026

Conditions

Keywords

Heart Rate VariabilityHRVAutonomic Nervous System

Outcome Measures

Primary Outcomes (5)

  • 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.

    Baseline, during a single study visit

  • 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.

    Baseline, during a single study visit

  • 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.

    Baseline, during a single study visit

  • 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.

    Baseline, during a single study visit.

  • 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.

    Baseline, during a single study visit.

Secondary Outcomes (12)

  • 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

  • +7 more secondary outcomes

Study Arms (1)

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.

Other: Heart Rate Variability and Blood Pressure Assessment

Interventions

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.

Healthy Adult Assessment Group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Artvin Coruh University, Artvin Vocational School, Disabled Care and Rehabilitation Laboratory, Artvin,

Artvin, Turkey (Türkiye)

Location

Related Publications (4)

  • 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: 26414314BACKGROUND
  • 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: 19910061BACKGROUND
  • 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: 8598068BACKGROUND
  • 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: 29034226BACKGROUND

Central Study Contacts

Sefa Haktan Hatık, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

April 6, 2026

First Posted

April 15, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

September 15, 2026

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations