Heart Rate Variability Augmentation With RR2 Neuromodulation Device

Hillel Yaffe Medical Center60 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

ReguRate neurostimulationDEVICE

Device: ReguRate neurostimulation Device: Sham : ReguRate neurostimulation - mock sham stimulation mode

Eligibility

Sex: ALLMin age: 25 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: \- 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

Locations (2)

Wingate Institute

Netanya, Israel

RECRUITING

Wingate Institute

Netanya, Israel

RECRUITING

Outcomes

Primary Outcomes

Percentage of patients with 15% or HRV change immediately after neurostimulation session

HRV augmentation

Time frame: 1 week

Secondary Outcomes

Decrease in heart rate

Percentage of patients with 5% or more decrease in heart rate

Time frame: 1 week

Central Contacts

Sharon Tsuk, PHD

CONTACT

972-9-8639368 sharontsuk1@gmail.com

Data from ClinicalTrials.gov

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