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Heart Rate Variability Augmentation With RR2 Neuromodulation Device

NCT ID: NCT03771794

Last Updated: 2018-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-15

Study Completion Date

2019-12-15

Brief Summary

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

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

Detailed Description

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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

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Healthy

Keywords

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HRV Peripheral neuromodulation Autonomic balance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Active Comparator: ReguRate RR2 active. Device: ReguRate neurostimulation system

Sham Comparator: ReguRate RR2 placebo. Device: Sham ReguRate electrical stimulation - mock sham stimulation mode
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active Comparator: ReguRate RR2 active

Device: ReguRate neurostimulation device

Group Type ACTIVE_COMPARATOR

ReguRate neurostimulation

Intervention Type DEVICE

Device: ReguRate neurostimulation Device:

Sham : ReguRate neurostimulation - mock sham stimulation mode

Sham Comparator: ReguRate RR2 sham.

Device: Sham ReguRate neurostimulation - mock sham stimulation mode

Group Type SHAM_COMPARATOR

ReguRate neurostimulation

Intervention Type DEVICE

Device: ReguRate neurostimulation Device:

Sham : ReguRate neurostimulation - mock sham stimulation mode

Interventions

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ReguRate neurostimulation

Device: ReguRate neurostimulation Device:

Sham : ReguRate neurostimulation - mock sham stimulation mode

Intervention Type DEVICE

Other Intervention Names

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Sham ReguRate neurostimulation - mock sham stimulation mode

Eligibility Criteria

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Inclusion Criteria

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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

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Prof. Ahud Sternberg

Chairman of Helsinki Ethics Committee

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Wingate Institute

Netanya, , Israel

Site Status RECRUITING

Wingate Institute

Netanya, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Sharon Tsuk, PHD

Role: CONTACT

Phone: 972-9-8639368

Email: [email protected]

Facility Contacts

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Sharon Tsuk, PhD

Role: primary

Sharon

Role: primary

Other Identifiers

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0024-18-HYMC

Identifier Type: -

Identifier Source: org_study_id