Heart Rate Variability Augmentation With RR2 Neuromodulation Device

Hillel Yaffe Medical Center

Status: Unknown

Conditions: Healthy

Treatments: Device: ReguRate neurostimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03771794

0024-18-HYMC

Details and patient eligibility

About

Brief Summary: A randomized double-blinded, sham-controlled, crossover study

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

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 25 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Active Comparator: ReguRate RR2 active

Active Comparator group

Description:

Device: ReguRate neurostimulation device

Treatment:

Device: ReguRate neurostimulation

Sham Comparator: ReguRate RR2 sham.

Sham Comparator group

Description:

Device: Sham ReguRate neurostimulation - mock sham stimulation mode

Treatment:

Device: ReguRate neurostimulation