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

NCT07616674 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 103

Last updated 2026-06-01

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • Federal University of São Paulo

    lead OTHER

Principal Investigators

  • Gisele Sampaio Silva, PhD · Federal University of São Paulo

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2025-12-15
Completion
2026-05-27
FDA Device
Yes

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07616674 on ClinicalTrials.gov