Non-invasive Modulation of Autonomic Cardiac Nervous System

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

Detailed Description
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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

Official Title
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Effects of Non Invasive Vagus Nerve Stimulation on Heart Rate Variability in Healthy Subjects and on Muscle Sympathetic Nerve Activity

Conditions
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Autonomic Nervous System, Heart Rate Variability, Muscle Sympathetic Nerve Activity

Intervention / Treatment
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* Other: Modulation of muscle sympathetic nerve activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers >18 years old Exclusion Criteria: pregnancy and breastfeeding smoke alcool/energy drinks/coffee consumption, exertion 24h before the participation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Randomized, controlled, double-blind, cross-over study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stimulation protocol<br>Each subject will be blinded and underwent 3 phases of stimulation (actives (2) and sham (1) comparators) in a randomized order . | Other: Modulation of muscle sympathetic nerve activity<br>* Assessment of muscle sympathetic nerve signal and exposition to external non invasive modulation.<br>|
| Sham Comparator: Sham stimulation protocol<br>Each subject will be blinded and underwent 3 phases of stimulation (actives (2) and sham (1) comparators) in a randomized order. | Other: Modulation of muscle sympathetic nerve activity<br>* Assessment of muscle sympathetic nerve signal and exposition to external non invasive modulation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability modulation | Modulation of heart rate variability assessed through analysis of MSNA signal | 4 hours | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart rate variability, MSNA, vagus nerve, sympathetic nervous system