Non-invasive Modulation of Autonomic Cardiac Nervous System

Not Applicable

• Conditions: Autonomic Nervous System; Heart Rate Variability; Muscle Sympathetic Nerve Activity
• Interventions: Other: Modulation of muscle sympathetic nerve activity

• Registration Number: NCT04057508
• Lead Sponsor: Université Catholique de Louvain

Brief Summary

To demonstrate the effect of non invasive vagus nerve (VNS) stimulation on heart rate variability and MSNA signal.

Detailed Description

First part: Assessment of the muscle sympathetic nerve activity (MSNA) at baseline using microneurography performed on the superficial peroneal nerve.

Second part: Acquisition of the MSNA signal during non-invasive VNS and apnea. Non-invasive VNS is performed using several frequencies of stimulation. Maximal and voluntaries apnea are performed at the end of the expiration.

Continuous recording of the following parameters:

* non-invasive arterial blood pressure

* R-R interval

* electrocardiogram

* MSNA activity

* respiratory curve signal

* respiratory rate, oxygen saturation

Study Timeline

• Study Start: 2019-06-19
• Status Verified: 2019-07
• Study First Submitted: 2019-08-13
• Study First Submitted QC: 2019-08-13
• Last Update Submitted: 2019-08-13
• Study First Posted: 2019-08-15
• Last Update Posted: 2019-08-15
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Healthy volunteers
• >18 years old

Exclusion Criteria

• pregnancy and breastfeeding
• smoke
• alcool/energy drinks/coffee consumption, exertion 24h before the participation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stimulation protocol	Modulation of muscle sympathetic nerve activity	Each subject will be blinded and underwent 3 phases of stimulation (actives (2) and sham (1) comparators) in a randomized order .
Sham stimulation protocol	Modulation of muscle sympathetic nerve activity	Each subject will be blinded and underwent 3 phases of stimulation (actives (2) and sham (1) comparators) in a randomized order.

Primary Outcome Measures

Name	Time	Method
Heart rate variability modulation	4 hours	Modulation of heart rate variability assessed through analysis of MSNA signal

Secondary Outcome Measures

Name	Time	Method
Non-invasive vagus nerve stimulation	4hours	Modulation of parasympathetic tone based on two different frequencies stimulation
Profile of response for MSNA	4 hours	To describe positive and negative patterns of MSNA response

Trial Locations

Locations (1)

Erasme University Hospital; 🇧🇪 Brussels, Belgium