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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health adults | Simultaneous EKG measurements, ICP waveform measurements, and Photoplethysmography. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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" |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy adults from 18 to 60 years old.
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| Name | Affiliation | Role |
|---|---|---|
| Gisele Sampaio Silva, PhD | Federal University of São Paulo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| São Paulo Hospital | São Paulo | São Paulo | 04024-002 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38610260 | Background | 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. | |
| 22350367 | 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. |
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Anonymous autonomic data (EKG, ICP waveform monitor, Photoplethysmography).
from 2026 after article publication.
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| 32811571 | 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. |
| 39139426 | 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. |