Heart Rate Variability Augmentation With RR2 Neuromodulation Device

December 10, 2018 updated by: Prof. Ahud Sternberg, Hillel Yaffe Medical Center

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Netanya, Israel
        • Recruiting
        • Wingate Institute
        • Contact:
          • Sharon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active Comparator: ReguRate RR2 active
Device: ReguRate neurostimulation device
Device: ReguRate neurostimulation

Device: ReguRate neurostimulation Device:

Sham : ReguRate neurostimulation - mock sham stimulation mode

Other Names:
  • Sham ReguRate neurostimulation - mock sham stimulation mode
Sham Comparator: Sham Comparator: ReguRate RR2 sham.
Device: Sham ReguRate neurostimulation - mock sham stimulation mode
Device: ReguRate neurostimulation

Device: ReguRate neurostimulation Device:

Sham : ReguRate neurostimulation - mock sham stimulation mode

Other Names:
  • Sham ReguRate neurostimulation - mock sham stimulation mode

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with 5% or more decrease in blood pressure
Time Frame: 1 week
1 week
Percentage of patients with change in additional HRV parameters (rMSSD, LF,HF,L/HF)
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillel Yaffe Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2018

Primary Completion (Anticipated)

November 15, 2019

Study Completion (Anticipated)

December 15, 2019

Study Registration Dates

First Submitted

December 9, 2018

First Submitted That Met QC Criteria

December 10, 2018

First Posted (Actual)

December 11, 2018

Study Record Updates

Last Update Posted (Actual)

December 11, 2018

Last Update Submitted That Met QC Criteria

December 10, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0024-18-HYMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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