Correlation Between the R-R Interval of the Electrocardiogram and the Intracranial Pulse Wave Int… (NCT07616674) | Clinical Trial Compass
CompletedNot Applicable
Correlation Between the R-R Interval of the Electrocardiogram and the Intracranial Pulse Wave Interval Assessed by a Noninvasive Method in Healthy People
Brazil103 participantsStarted 2025-06-01
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
Timeframe: "From enrollment to the end of recruitment at 8 weeks"