NCT04057508

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 19, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 15, 2019

Status Verified

July 1, 2019

Enrollment Period

6 months

First QC Date

August 13, 2019

Last Update Submit

August 13, 2019

Conditions

Autonomic Nervous SystemHeart Rate VariabilityMuscle Sympathetic Nerve Activity

Keywords

Heart rate variability, MSNA, vagus nerve, sympathetic nervous system

Outcome Measures

Primary Outcomes (1)

  • Heart rate variability modulation

    Modulation of heart rate variability assessed through analysis of MSNA signal

    4 hours

Secondary Outcomes (2)

  • Non-invasive vagus nerve stimulation

    4hours

  • Profile of response for MSNA

    4 hours

Other Outcomes (1)

  • Profile of response of MSNA during prolonged breath hold

    4hours

Study Arms (2)

Stimulation protocol

ACTIVE COMPARATOR

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

Sham stimulation protocol

SHAM COMPARATOR

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

Interventions

Modulation of muscle sympathetic nerve activityOTHER

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

Sham stimulation protocolStimulation protocol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers
  • \>18 years old

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasme University Hospital

Brussels, 1070, Belgium

RECRUITING

Central Study Contacts

Anaïs Gauthey, MD

CONTACT

027682888anais.gauthey@uclouvain.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Investigators are double-blinded for both experimental procedures and data analyzes. Volunteers are blinded to the site of stimulation.
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Randomized, controlled, double-blind, cross-over study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2019

First Posted

August 15, 2019

Study Start

June 19, 2019

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

August 15, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)