Status unknownNCT03771794Updated Dec 11, 2018

Heart Rate Variability Augmentation With RR2 Neuromodulation Device

An interventional study of ReguRate neurostimulation in Healthy, sponsored by Hillel Yaffe Medical Center. Status unknown at 2 sites in Israel. Open to participants aged 25 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-11.

Sponsored by Hillel Yaffe Medical Center · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2018), so the status shown — last known as Recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 60
Allocation: Randomized
Ages: 25 Years to 60 Years
Sex: All

Study summary

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

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

Read the 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

Conditions studied

Healthy

Keywords

HRV
Peripheral neuromodulation
Autonomic balance

In context

Lead sponsor

Hillel Yaffe Medical Center is the lead sponsor of 301 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 25 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Eligibility criteria

Inclusion Criteria:

Inclusion criteria :

Healthy male and female volunteers ages 25-60
2 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

Exclusion Criteria:

Exclusion criteria :

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Investigator)
Enrollment: 60 participants (estimated)

Study arms

Active comparator
Active Comparator: ReguRate RR2 active
Device: ReguRate neurostimulation device
Device: ReguRate neurostimulation
Sham comparator
Sham Comparator: ReguRate RR2 sham.
Device: Sham ReguRate neurostimulation - mock sham stimulation mode
Device: ReguRate neurostimulation

Interventions

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

What researchers measure

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

Other outcomes

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

Study locations

2 of 2 sites recruiting

Wingate Institute
Netanya, Israel
- Sharon Tsuk, PhD · Contact
- Raffael Carasso, MD · Principal investigator
- Sharon Tsuk, PhD · Sub investigator
Recruiting
Wingate Institute
Netanya, Israel
- Sharon · Contact
Recruiting

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 11, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03771794
Lead sponsor: Hillel Yaffe Medical Center
Responsible party: Prof. Ahud Sternberg (Chairman of Helsinki Ethics Committee, Hillel Yaffe Medical Center) — Principal investigator
First posted: Dec 11, 2018
Start date: Nov 15, 2018
Primary completion: Nov 15, 2019 (estimated)
Completion: Dec 15, 2019 (estimated)
Last update: Dec 11, 2018

Study contacts

Sharon Tsuk, PHD

Contact

sharontsuk1@gmail.com

972-9-8639368

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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