Status:
UNKNOWN
Heart Rate Variability Augmentation With RR2 Neuromodulation Device
Lead Sponsor:
Hillel Yaffe Medical Center
Conditions:
Healthy
Eligibility:
All Genders
25-60 years
Phase:
NA
Brief Summary
Brief Summary: A randomized double-blinded, sham-controlled, crossover study Condition or Disease: impaired autonomic balance measured by heart rate variability
Detailed Description
A randomized double-blinded, sham-controlled, crossover study Condition or Disease: impaired autonomic balance measured by heart rate variability Intervention/treatment: Device: ReguRate RR2 neuros...
Eligibility Criteria
Inclusion
- \-
- Inclusion criteria :
- Healthy male and female volunteers ages 25-60
- 2 minute HRV measurement with SDNN\<35 ms (below 35 ms)
- Participants able and willing to comply with the study protocol
- Participants able and willing to sign a written informed consent
Exclusion
- \-
- Exclusion criteria :
- Participant with a known cardiovascular disease
- Participants with COPD
- Participants with any known history of epilepsy
- Participants with detected arrhythmia on test day
- Participants with implanted electrical and/or neurostimulation device (such as cardiac pace maker/defibrillator/VNS stimulator/SNS stimulator/occipital nerve stimulator/deep brain stimulator etc.)
- Heavy smokers (more than 1 package of cigarets a day)
- Participants with a plan to change medications
- History of vasovagal syncope
- Pregnancy or bleeding
- Participants enrolled in another clinical trial
Key Trial Info
Start Date :
November 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03771794
Start Date
November 15 2018
End Date
December 15 2019
Last Update
December 11 2018
Active Locations (2)
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1
Wingate Institute
Netanya, Israel
2
Wingate Institute
Netanya, Israel