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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Comparator: ReguRate RR2 active | Active Comparator | Device: ReguRate neurostimulation device |
|
| Sham Comparator: ReguRate RR2 sham. | Sham Comparator | Device: Sham ReguRate neurostimulation - mock sham stimulation mode |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReguRate neurostimulation | Device | Device: ReguRate neurostimulation Device: Sham : ReguRate neurostimulation - mock sham stimulation mode |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with 15% or HRV change immediately after neurostimulation session | HRV augmentation | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in heart rate | Percentage of patients with 5% or more decrease in heart rate | 1 week |
| Measure | Description | 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 |
Inclusion Criteria:
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Inclusion criteria :
Exclusion Criteria:
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Exclusion criteria :
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sharon Tsuk, PHD | Contact | 972-9-8639368 | sharontsuk1@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wingate Institute | Recruiting | Netanya | Israel |
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Active Comparator: ReguRate RR2 active. Device: ReguRate neurostimulation system
Sham Comparator: ReguRate RR2 placebo. Device: Sham ReguRate electrical stimulation - mock sham stimulation mode
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| Wingate Institute | Recruiting | Netanya | Israel |
|