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Non-invasive Vagus Nerve Stimulation and Sleep in Healthy Volunteers.

NCT06928441 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-04-15

No results posted yet for this study

Summary

Participants will be chosen at random to receive a 30-minute stimulation of a specialized nerve (called a vagus nerve). The aim of this study is to determine whether a battery-operated portable device (current adjustable) attached to the outer ears (tragus) makes one more likely to improve on their sleep and quality of daily life. Participants will visit the lab on 2 occasions (one with a stimulating device and one without), 3 weeks apart for detailed instruction on setting up the ear stimulation and sleep kit in their home. Researchers will compare the sleep results from a PSG sleep device from the 2 sessions to determine the effect, if any on sleep.

Conditions

  • Sleep

Interventions

DEVICE

Transcutaneous Pulsed Electrical Stimulation (Device: WL-2103A)

The Transcutaneous Electrical Nerve Stimulator (TENS) creates electrical impulses from a 9VDC-battery whose continuous intensity rate can be controlled by the user. The alligator clip with 2 electrodes is placed on the tragus part of the ear (shown to be 45% innervated via auricular vagus nerve) to stimulate the vagus nerve with an adjustable peak intensity (0-80mA), a frequency of 2 - 250Hz and a pulse width of 30-260 µsec. The vagus nerve contains a mixture of different types of nerve fibres, which are organized into bundles (fascicles). The fibres vary in diameter and conduction velocity, with A-type fibres the largest and fastest and C-type fibres the smallest and slowest, with B-type fibres intermediate. During nerve stimulation, fibres are activated in order of size from the largest (A-type) to the smallest (C-type). It has been suggested that A-type fibres are mainly activated during the stimulation via auricular vagus nerve.

Sponsors & Collaborators

  • Natural Sciences and Engineering Research Council, Canada

    collaborator OTHER

  • University of Calgary

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2029-04-30
Completion
2029-04-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06928441 on ClinicalTrials.gov