Non-invasive Modulation of Autonomic Cardiac Nervous System

NCT ID: NCT04057508

Last Updated: 2019-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-19

Study Completion Date

2019-12-31

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

Conditions

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Autonomic Nervous System Heart Rate Variability Muscle Sympathetic Nerve Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Randomized, controlled, double-blind, cross-over study
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators
Investigators are double-blinded for both experimental procedures and data analyzes.

Volunteers are blinded to the site of stimulation.

Study Groups

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Stimulation protocol

Each subject will be blinded and underwent 3 phases of stimulation (actives (2) and sham (1) comparators) in a randomized order .

Group Type ACTIVE_COMPARATOR

Modulation of muscle sympathetic nerve activity

Intervention Type OTHER

Assessment of muscle sympathetic nerve signal and exposition to external non invasive modulation.

Sham stimulation protocol

Each subject will be blinded and underwent 3 phases of stimulation (actives (2) and sham (1) comparators) in a randomized order.

Group Type SHAM_COMPARATOR

Modulation of muscle sympathetic nerve activity

Intervention Type OTHER

Assessment of muscle sympathetic nerve signal and exposition to external non invasive modulation.

Interventions

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Modulation of muscle sympathetic nerve activity

Assessment of muscle sympathetic nerve signal and exposition to external non invasive modulation.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Erasme University Hospital

OTHER

Sponsor Role collaborator

Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Erasme University Hospital

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Anaïs Gauthey, MD

Role: CONTACT

027682888 ext. 0032

Facility Contacts

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Anaïs Gauthey, MD

Role: primary

025555919 ext. 0032

SRB Service de Recherche Biomédicale

Role: backup

02 25 55 83 51 ext. 0032

Other Identifiers

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TFE_201904_097

Identifier Type: -

Identifier Source: org_study_id

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