Non-Invasive Peripheral Neuromodulation to Augment HRV in Healthy Adults
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- Hillel Yaffe Medical Center
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Percentage of patients with 15% or HRV change immediately after neurostimulation session
- Last Updated
- 7 years ago
Overview
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 neurostimulation system Device: Sham ReguRate RR2 neurostimulation system Study Design: Study Type: Interventional (clinical trial) Planned enrollment: 60 participants Allocation: Randomized Intervention Model; Cross Over Masking: Double (participant, Investigator) Primary Purpose: Treatment Official Title: Non-Invasive peripheral neuromodulation to augment HRV in healthy adults
Investigators
Prof. Ahud Sternberg
Chairman of Helsinki Ethics Committee
Hillel Yaffe Medical Center
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Percentage of patients with 15% or HRV change immediately after neurostimulation session
Time Frame: 1 week
HRV augmentation
Secondary Outcomes
- Decrease in heart rate(1 week)