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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07616674
Enrollment
103
Registered
2026-06-01
Start date
2025-06-01
Completion date
2026-05-27
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

DIAGNOSTIC_TESTEvaluate 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

Federal University of São Paulo
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy adults from 18 to 60 years old.

Exclusion criteria

* The

Design outcomes

Primary

MeasureTime frameDescription
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."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.

Countries

Brazil

Contacts

STUDY_DIRECTORGisele Sampaio Silva, PhD

Federal University of São Paulo

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 2, 2026