Heart Rate Variability (HRV)NCT07616674
Correlation Between the R-R Interval of the Electrocardiogram and the Intracranial Pulse Wave Interval Assessed by a Noninvasive Method in Healthy People
An observational study of Heart Rate Variability (HRV) and Intracranial Pressure Change, run by Federal University of São Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Rate Variability (HRV), Intracranial Pressure Change, Pulse Rate
- What is being tested?
- 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
- How many people
- 103 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2025to 27 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy adults from 18 to 60 years old.
Who may be able to join
- Healthy adults from 18 to 60 years old.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- 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
- Keywords
- intracranial pulse waveform, intracranial compliance, heart rate variability, brain rate variability, autonomic nervous system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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, RDiagnostic test
Simultaneous Autonomic measures using ECG, noninvasive ICP wave monitor and photoplethysmography (oximeter)
| Study group | Role | What they receive |
|---|---|---|
| Health adults | Simultaneous EKG measurements, ICP waveform measurements, and Photoplethysmography. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: "From enrollment to the end of recruitment at 8 weeks"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start1 Jun 2025
- Primary completion15 Dec 2025
- Study completion27 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart Rate Variability (HRV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gisele Sampaio Silva, Federal University of São Paulo
- Investigators
- Gisele Sampaio Silva, PhD, Study director, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616674
- Sponsor's protocol ID
- 83670224.6.0000.5505
- Status last verified
- May 2026
- First submitted
- 10 Sep 2025
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Anonymous autonomic data (EKG, ICP waveform monitor, Photoplethysmography).
Publications
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.
PubMed 38610260Wong 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.
PubMed 22350367Yuda 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.
PubMed 32811571Pilz 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.
PubMed 39139426
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between the R-R Interval of the Electrocardiogram and the Intracranial Pulse Wave Interval Assessed by a Noninvasive Method in Healthy People
- ClinicalTrials.gov ID
- NCT07616674
- Acronym / sponsor ID
- 83670224.6.0000.5505
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 27 May 2026 (actual)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health adults | – | 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, RSimultaneous EKG measurements, ICP waveform measurements, and Photoplethysmography. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy adults from 18 to 60 years old.
Key inclusion criteria (1 listed)
- Healthy adults from 18 to 60 years old.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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, RSimultaneous Autonomic measures using ECG, noninvasive ICP wave monitor and photoplethysmography (oximeter) | Diagnostic test | Health adults |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Background: PubMed 38610260Burma 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.
- Background: PubMed 22350367Wong 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.
- Background: PubMed 32811571Yuda 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.
- Background: PubMed 39139426Pilz 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.
- Individual participant dataSharing planned: Yes. Anonymous autonomic data (EKG, ICP waveform monitor, Photoplethysmography).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gisele Sampaio Silva, PhD study director
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Rate Variability (HRV) and Intracranial Pressure Change, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07616674, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.