Heart Rate Variability Augmentation With RR2 Neuromodulation Device

Non-Invasive Peripheral Neuromodulation to Augment HRV in Healthy Adults

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:

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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