Heart Rate Variability Augmentation With RR2 Neuromodulation Device

Study Overview
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Brief Summary
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Brief Summary: A randomized double-blinded, sham-controlled, crossover study Condition or Disease: impaired autonomic balance measured by heart rate variability

Detailed Description
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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

Official Title
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Non-Invasive Peripheral Neuromodulation to Augment HRV in Healthy Adults

Conditions
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Healthy

Intervention / Treatment
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* Device: ReguRate neurostimulation


Participation Criteria
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Eligibility Criteria
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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 Participants enrolled in another clinical trial

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Active Comparator: ReguRate RR2 active. Device: ReguRate neurostimulation system Sham Comparator: ReguRate RR2 placebo. Device: Sham ReguRate electrical stimulation - mock sham stimulation mode
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Comparator: ReguRate RR2 active<br>Device: ReguRate neurostimulation device | Device: ReguRate neurostimulation<br>* Device: ReguRate neurostimulation Device: Sham : ReguRate neurostimulation - mock sham stimulation mode<br>* Other names: Sham ReguRate neurostimulation - mock sham stimulation mode;|
| Sham Comparator: Sham Comparator: ReguRate RR2 sham.<br>Device: Sham ReguRate neurostimulation - mock sham stimulation mode | Device: ReguRate neurostimulation<br>* Device: ReguRate neurostimulation Device: Sham : ReguRate neurostimulation - mock sham stimulation mode<br>* Other names: Sham ReguRate neurostimulation - mock sham stimulation mode;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with 15% or HRV change immediately after neurostimulation session | HRV augmentation | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in heart rate | Percentage of patients with 5% or more decrease in heart rate | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HRV, Peripheral neuromodulation, Autonomic balance