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

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.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

São Paulo Hospital

São Paulo, 04024-002, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy adults from 18 to 60 years old.

Exclusion criteria

The exclusion criteria were as follows: (1) diagnosed cardiovascular disease, including arrythmia (2) symptoms of illness during the recruitment time, (3) restriction in physical activity, and (4) restriction on using wearable devices.

Treatment and study plan

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)

Primary outcomes

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.

Time frame: "From enrollment to the end of recruitment at 8 weeks"

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.

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2026
First posted: Jun 1, 2026
Registry last updated: Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed