Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-03-13 @ 1:03 PM
Study NCT ID:
NCT03771794
Status:
UNKNOWN
Last Update Posted:
2018-12-11
First Post:
2018-12-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heart Rate Variability Augmentation With RR2 Neuromodulation Device
Sponsor:
Hillel Yaffe Medical Center
Organization:
Study Overview
Official Title:
Non-Invasive Peripheral Neuromodulation to Augment HRV in Healthy Adults
Status:
UNKNOWN
Status Verified Date:
2018-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Brief Summary: A randomized double-blinded, sham-controlled, crossover study
Condition or Disease: impaired autonomic balance measured by heart rate variability
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: