Heart Rate Variability Augmentation With RR2 Neuromodulation Device

NCT03771794 | Unknown DMC

• 1 other identifier: 0024-18-HYMC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Healthy

Keywords

HRV; Peripheral neuromodulation; Autonomic balance

Outcome Measures

Primary Outcomes (1)

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

  HRV augmentation

  1 week

Secondary Outcomes (1)

• Decrease in heart rate

  1 week

Other Outcomes (2)

• Percentage of patients with 5% or more decrease in blood pressure

  1 week

• Percentage of patients with change in additional HRV parameters (rMSSD, LF,HF,L/HF)

  1 week

Study Arms (2)

Active Comparator: ReguRate RR2 active

ACTIVE COMPARATOR

Device: ReguRate neurostimulation device

Device: ReguRate neurostimulation

Sham Comparator: ReguRate RR2 sham.

SHAM COMPARATOR

Device: Sham ReguRate neurostimulation - mock sham stimulation mode

Device: ReguRate neurostimulation

Interventions

ReguRate neurostimulation DEVICE

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

Also known as: Sham ReguRate neurostimulation - mock sham stimulation mode

Active Comparator: ReguRate RR2 active; Sham Comparator: ReguRate RR2 sham.

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and female volunteers ages 25-60
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hillel Yaffe Medical Center: lead

Study Sites (2)

Wingate Institute

Netanya, Israel

RECRUITING

Wingate Institute

Netanya, Israel

RECRUITING

Central Study Contacts

Sharon Tsuk, PHD

CONTACT

972-9-8639368; sharontsuk1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of Helsinki Ethics Committee

Model Details: Active Comparator: ReguRate RR2 active. Device: ReguRate neurostimulation system Sham Comparator: ReguRate RR2 placebo. Device: Sham ReguRate electrical stimulation - mock sham stimulation mode

Study Record Dates

• First Submitted: December 9, 2018
• First Posted: December 11, 2018
• Study Start: November 15, 2018
• Primary Completion: November 15, 2019
• Study Completion: December 15, 2019
• Last Updated: December 11, 2018

Record last verified: 2018-12

Locations

IL (2)