Correlation Between the R-R Interval of the Electrocardiogram and the Intracranial Pulse Wave Interval Assessed by a Noninvasive Method in Healthy People

NCT07616674 | Completed DMC FDA Device

• 1 other identifier: 83670224.6.0000.5505
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

Heart rate variability (HRV) is a well-established cardiovascular and autonomic health metric in the medical literature. However, its applicability is limited by the difficulty of analysis and interpretation in clinical practice. Given that the intracranial pressure (ICP) waveform is the manifestation of the vascular pulse wave that originates from cardiac muscle contraction, we will evaluate whether the interval between ICP pulse waves assessed noninvasively with Brain4care technology is the same as the R-R interval assessed by electrocardiography in healthy patients, in an attempt to universalize autonomic analysis in clinical practice.

Conditions

Heart Rate Variability (HRV); Intracranial Pressure Change; Pulse Rate; Autonomic Nervous System Activity

Keywords

intracranial pulse waveform; intracranial compliance; heart rate variability; brain rate variability; autonomic nervous system

Outcome Measures

Primary Outcomes (1)

• Evaluate the correlation between R-R interval and R-R equivalent on the noninvasive intracranial compliance monitor and evaluate their correspondence considering the Time domain (HR, NN, NN50, RMSSD, SDNN, pNN50) in health patients.

  The participants will be asked to wear the noninvasive ICP waveform monitor band, an EKG and finger oximeter (photoplethysmography) monitor for 15 minutes in supine position with an 15-degree head elevation. All recordings were performed in a bright and quiet room.

  "From enrollment to the end of recruitment at 8 weeks"

Study Arms (1)

Health adults

Simultaneous EKG measurements, ICP waveform measurements, and Photoplethysmography.

Diagnostic Test: Evaluate the correlation between R-R interval and R-R equivalent on the noninvasive intracranial compliance monitor (BRV) and evaluate their correspondence considering the Time domain (HR, NN, NN50, R

Interventions

Evaluate the correlation between R-R interval and R-R equivalent on the noninvasive intracranial compliance monitor (BRV) and evaluate their correspondence considering the Time domain (HR, NN, NN50, R DIAGNOSTIC_TEST

Simultaneous Autonomic measures using ECG, noninvasive ICP wave monitor and photoplethysmography (oximeter)

Health adults

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy adults from 18 to 60 years old.

You may qualify if:

• Healthy adults from 18 to 60 years old.

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

São Paulo Hospital

São Paulo, São Paulo, 04024-002, Brazil

Location

Related Publications (4)

• Burma JS, Griffiths JK, Lapointe AP, Oni IK, Soroush A, Carere J, Smirl JD, Dunn JF. Heart Rate Variability and Pulse Rate Variability: Do Anatomical Location and Sampling Rate Matter? Sensors (Basel). 2024 Mar 23;24(7):2048. doi: 10.3390/s24072048.

  PMID: 38610260 BACKGROUND

• Wong JS, Lu WA, Wu KT, Liu M, Chen GY, Kuo CD. A comparative study of pulse rate variability and heart rate variability in healthy subjects. J Clin Monit Comput. 2012 Apr;26(2):107-14. doi: 10.1007/s10877-012-9340-6. Epub 2012 Feb 19.

  PMID: 22350367 BACKGROUND

• Yuda E, Shibata M, Ogata Y, Ueda N, Yambe T, Yoshizawa M, Hayano J. Pulse rate variability: a new biomarker, not a surrogate for heart rate variability. J Physiol Anthropol. 2020 Aug 18;39(1):21. doi: 10.1186/s40101-020-00233-x.

  PMID: 32811571 BACKGROUND

• Pilz N, Heinz V, Ax T, Fesseler L, Patzak A, Bothe TL. Pulse Wave Velocity: Methodology, Clinical Applications, and Interplay with Heart Rate Variability. Rev Cardiovasc Med. 2024 Jul 17;25(7):266. doi: 10.31083/j.rcm2507266. eCollection 2024 Jul.

  PMID: 39139426 BACKGROUND

Study Officials

• Gisele Sampaio Silva, PhD

  Federal University of São Paulo

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: June 1, 2026
• Study Start: June 1, 2025
• Primary Completion: December 15, 2025
• Study Completion: May 27, 2026
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: from 2026 after article publication.

Locations

BR (1)