Heart Rate Variability Augmentation With RR2 Neuromodulation Device
Heart Rate Variability Augmentation With RR2 Neuromodulation Device
Brief Summary: A randomized double-blinded, sham-controlled, crossover study

 Condition or Disease: impaired autonomic balance measured by heart rate variability
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
Inclusion Criteria:

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 Inclusion criteria :

 1. Healthy male and female volunteers ages 25-60

 2. 2 minute HRV measurement with SDNN<35 ms (below 35 ms)

 3. Participants able and willing to comply with the study protocol

 4. Participants able and willing to sign a written informed consent

 Exclusion Criteria:

 -

 Exclusion criteria :

 1. Participant with a known cardiovascular disease

 2. Participants with COPD

 3. Participants with any known history of epilepsy

 4. Participants with detected arrhythmia on test day

 5. 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.)

 6. Heavy smokers (more than 1 package of cigarets a day)

 7. Participants with a plan to change medications

 8. History of vasovagal syncope

 9. Pregnancy or bleeding

 10. Participants enrolled in another clinical trial