HealthyNCT03771794
Heart Rate Variability Augmentation With RR2 Neuromodulation Device
A study testing ReguRate neurostimulation in people with Healthy, run by Hillel Yaffe Medical Center at 2 sites in Israel.
Trial summary
Brief Summary: A randomized double-blinded, sham-controlled, crossover study Condition or Disease: impaired autonomic balance measured by heart rate variability Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ReguRate neurostimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesIsrael
- Study dates
- 15 Nov 2018to 15 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -
- 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
Who cannot join
- -
- 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.)
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Recruiting
Wingate Institute
Netanya
Sharon Tsuk, PhD
Raffael Carasso, MD
- Recruiting
Wingate Institute
Netanya
Sharon
About this study
Official title: 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
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
- Healthy
- Being tested
- ReguRate neurostimulation
- Keywords
- HRV, Peripheral neuromodulation, Autonomic balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReguRate neurostimulationDevice
Also called Sham ReguRate neurostimulation - mock sham stimulation mode
Device: ReguRate neurostimulation Device:
Sham : ReguRate neurostimulation - mock sham stimulation mode
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: ReguRate RR2 active | Active comparator | Device: ReguRate neurostimulation device Receives: Device: ReguRate neurostimulation |
| Sham Comparator: ReguRate RR2 sham. | Sham comparator | Device: Sham ReguRate neurostimulation - mock sham stimulation mode Receives: Device: ReguRate neurostimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with 15% or HRV change immediately after neurostimulation session
HRV augmentation
Measured: 1 week
Secondary outcomes (1)
Decrease in heart rate
Percentage of patients with 5% or more decrease in heart rate
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start15 Nov 2018
- Primary completion15 Nov 2019 (estimated)
- Study completion15 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Ahud Sternberg, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03771794
- Sponsor's protocol ID
- 0024-18-HYMC
- Status last verified
- Dec 2018
- First submitted
- 9 Dec 2018
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Peripheral Neuromodulation to Augment HRV in Healthy Adults
- ClinicalTrials.gov ID
- NCT03771794
- Acronym / sponsor ID
- 0024-18-HYMC
- Conditions
- Healthy
- Keywords
- HRV, Peripheral neuromodulation, Autonomic balance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 15 Nov 2019 (estimated)
- Study completion
- 15 Dec 2019 (estimated)
- First posted
- 11 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: ReguRate RR2 active | Active comparator | Device: ReguRate neurostimulationDevice: ReguRate neurostimulation device |
| Sham Comparator: ReguRate RR2 sham. | Sham comparator | Device: ReguRate neurostimulationDevice: Sham ReguRate neurostimulation - mock sham stimulation mode |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- -
- 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
Key exclusion criteria (11 listed)
- -
- Participant with a known cardiovascular disease
- Participants with COPD
- Participants with any known history of epilepsy
- Participants with detected arrhythmia on test day
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReguRate neurostimulationAlso: Sham ReguRate neurostimulation - mock sham stimulation modeDevice: ReguRate neurostimulation Device: Sham : ReguRate neurostimulation - mock sham stimulation mode | Device | Active Comparator: ReguRate RR2 active, Sham Comparator: ReguRate RR2 sham. |
Primary outcome
Percentage of patients with 15% or HRV change immediately after neurostimulation session
Time frame: 1 week
HRV augmentation
1 secondary outcome
Decrease in heart rate
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReguRate neurostimulation in people with Healthy, run by Hillel Yaffe Medical Center at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sharon Tsuk, PHD (972-9-8639368, sharontsuk1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with 15% or HRV change immediately after neurostimulation session (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2018.