NCT03771794

Heart Rate Variability Augmentation With RR2 Neuromodulation Device

Non-Invasive Peripheral Neuromodulation to Augment HRV in Healthy Adults

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Hillel Yaffe Medical Center · Other Government
• Sex: All
• Age: 25 Years – 60 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy

Interventions

Type	Name	Description
DEVICE	ReguRate neurostimulation	Device: ReguRate neurostimulation Device: Sham : ReguRate neurostimulation - mock sham stimulation mode

Timeline

• Start date: 2018-11-15
• Primary completion: 2019-11-15
• Completion: 2019-12-15
• First posted: 2018-12-11
• Last updated: 2018-12-11

Locations

2 sites across 1 country: Israel