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

NCT06928441 | Not Yet Recruiting

• 1 other identifier: REB24-1438
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Neuromodulation, Vagus nerve

Outcome Measures

Primary Outcomes (1)

• Change in Sleep Quality Evaluated by Polysomnography

  Investigators believe this device encourages increases in vagal tone associated with increases in baroreflex sensitivity, improving sleep and possibly leading to an increase in quality of life.

  4 weeks

Study Arms (2)

Trial Arm 1

EXPERIMENTAL

Participants and experimenters are blinded. 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. Investigators believe this device encourages increases in vagal tone associated with increases in baroreflex sensitivity, improving sleep and possibly leading to an increase in quality of life.

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

Trial Arm 2

EXPERIMENTAL

Participants and experimenters are blinded. 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. Investigators believe this device encourages increases in vagal tone associated with increases in baroreflex sensitivity, improving sleep and possibly leading to an increase in quality of life.

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

Interventions

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

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.

Also known as: Transcutaneous auricular vagal nerve stimulator, Transcutaneous Electrical Nerve Stimulator

Trial Arm 1; Trial Arm 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female, aged ≥ 18 and \< 50 years.
• In good health with no evidence of medical problems.
• Ability to provide informed consent and willingness to comply with the study procedures.
• Ability to use a battery operated electro-stimulating device attached to your ears for 30 minutes.
• Ability to breathe through the nose comfortably and wear a sleep monitoring device.

You may not qualify if:

• Obesity (BMI \> 40 kg/m2).
• Known history of heart, lung, kidney, or liver disease.
• Diagnosis of asthma or sleep apnea.
• Diagnosis of diabetes.
• Current smoker.
• Pregnancy or lactation due to the location of the sleep devices.
• Resting heart rate \> 120 bpm.
• Systolic BP \> 150, diastolic BP \> 90.
• Presence of any other condition that, in the opinion of the PI, makes the individual unsuitable for participation.

Sponsors & Collaborators

• University of Calgary: lead
• Natural Sciences and Engineering Research Council, Canada: collaborator

Study Sites (1)

Unviersity of Calgary

Calgary, Alberta, T2N 4N1, Canada

Location

Central Study Contacts

Marc J Poulin, PhD, DPhil, FPhysiol

CONTACT

1-403-220-8372; poulin@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 15, 2025
• Study Start: April 30, 2025
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029
• Last Updated: April 15, 2025

Record last verified: 2025-04

Locations

CA (1)