Heart Rate Variability Augmentation With RR2 Neuromodulation Device

Healthy Clinical Trial

Official title:

Non-Invasive Peripheral Neuromodulation to Augment HRV in Healthy Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03771794
• Other study ID #: 0024-18-HYMC
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2018
• Est. completion date: December 15, 2019

Study information

• Verified date: December 2018
• Source: Hillel Yaffe Medical Center
• Contact: Sharon Tsuk, PHD
• Phone: 972-9-8639368
• Email: sharontsuk1[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 15, 2019
• Est. primary completion date: November 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Israel	Wingate Institute	Netanya
Israel	Wingate Institute	Netanya

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of patients with 5% or more decrease in blood pressure		1 week
Other	Percentage of patients with change in additional HRV parameters (rMSSD, LF,HF,L/HF)		1 week
Primary	Percentage of patients with 15% or HRV change immediately after neurostimulation session	HRV augmentation	1 week
Secondary	Decrease in heart rate	Percentage of patients with 5% or more decrease in heart rate	1 week