Heart Rate Variability Augmentation With RR2 Neuromodulation Device

Non-Invasive Peripheral Neuromodulation to Augment HRV in Healthy Adults

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03771794

Enrollment

Registered

2018-12-11

Start date

2018-11-15

Completion date

2019-12-15

Last updated

2018-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

HRV, Peripheral neuromodulation, Autonomic balance

Brief summary

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

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

Interventions

DEVICEReguRate neurostimulation

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

25 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Other

Measure	Time frame
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

Countries

Israel

Contacts

Primary ContactSharon Tsuk, PHD

sharontsuk1@gmail.com972-9-8639368

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026