SleepNCT06928441
Non-invasive Vagus Nerve Stimulation and Sleep in Healthy Volunteers.
A study testing Transcutaneous Pulsed Electrical Stimulation (Device: WL-2103A) in people with Sleep, run by University of Calgary at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Transcutaneous Pulsed Electrical Stimulation (Device: WL-2103A)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 30 Apr 2025to 30 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Unviersity of Calgary
Calgary, Alberta, T2N 4N1
Marc Poulin, PhD, 403-220-8372, poulin@ucalgary.ca
About this study
Official title: Non-invasive Vagus Nerve Stimulation and Sleep in Healthy Volunteers: a Randomized Trial.
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.
Read the detailed description
The purpose of this study is to determine whether a 30-minute stimulation of the vagus nerve at the site of the tragus area of the outer ear, helps to improve sleep efficiency in healthy participants. The vagus nerve protects the heart and vital organs, by feeding back information to the brain, and subsequently mounting a protective response. The aim is to identify any potential benefits of a device to boost function of the vagus nerve.
The battery-operated portable electro-stimulator (sham, or active) (Transcutaneous auricular vagal nerve stimulation) is designed to be attached to the outer ear. The Transcutaneous Electrical Nerve Stimulator (TENS) (Model WL-2103A): 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 micro-sec. 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. It has been shown that a decrease in sympathetic activity and increase of parasympathetic modulation of the heart (controlled by the vagus nerve) creates the transition from wake to sleep states. Thus, stimulating the vagus nerve may maintain a balance of the autonomic nervous system and therefore, affect the quality of sleep.
The self-instrumented sleep evaluation device is a polysomnography (PSG) level 2 + ECG Prodigy Sleep System consisting of a chest mounted unit (CMU) that records heart-rate (ECG), breathing-rate (nasal cannula), chest and stomach movements, and leg movements. The head mounted unit (HMU) measures electroencephalogram (EEG) of the frontal lobe, eye and chin movements. The wrist unit records blood oxygen saturation (SpO2) and pulse rate. All the wearable devices sends the specific data to the table-top tablet (TTU) via Bluetooth. The system uses secured web-based PSG to analyze the EEG, electrooculogram (EOC), ECG, electromyogram, accelerometry, acoustic signals, nasal airflow, thoracic and abdomen respiratory effect, pulse rate and oxy-hemoglobin saturation. All results are scored using Michele Sleep Scoring System to create necessary files showing all the stages of sleep (N1, N2, N3, REM) including sleep length, desaturation and efficiency.
40-50 Participants will be asked to attend five study visits over a 1-2 month period:
- Laboratory visit 1: Informed consent, screening (~ 1 hour)
- Laboratory visit 2: Assessment of neuromodulation stimulation level using the lab stimulation device and demonstration of how-to self-instrument the Cerebra Sleep monitoring kit at their personal residence for 4 nights consecutively. Participants will be assigned to either a sham, or active stim device to self-administer and given the sleep questionnaires for each night. (~ 2 hours)
- Laboratory visit 3: Return the equipment and questionnaires and de-brief on the past 4 nights (~ 30 mins)
- Laboratory visit 4: (after 21-day washout period): Re-assessment of neuromodulation stimulation level and re-issue of a sleep kit. (~ 2 hours)
- Laboratory visit 5: Return the equipment and debrief on the past 4 nights. (~30 mins)
During the laboratory visits, participants will be trained on how to complete a full self-instrumentation using the sleep unit. For the ear neuro-stimulator, participants will respond to the tester's prompts as they experience increases in the level of stimulation. Participants will then be chosen at random to receive either the 30 minutes of outer ear stimulation, or no stimulation since the final setting of the neuro-stimulator will not be observable.
The analysis will be conducted using a two-tailed, two sample t-test on the first intervention to determine there were no significant differences within the 2 groups (sham, or active). T-test for differences between the two groups.
All the sleep data will be encrypted and transferred to a secure database and all hard copied data will be separated from identifiers into a locked file storage system.
Once the study is finished, the participants will have the option to view individual results.
- Conditions
- Sleep
- Being tested
- Transcutaneous Pulsed Electrical Stimulation (Device: WL-2103A)
- Keywords
- Neuromodulation, Vagus nerve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Pulsed Electrical Stimulation (Device: WL-2103A)Device
Also called Transcutaneous auricular vagal nerve stimulator, Transcutaneous Electrical Nerve Stimulator
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Transcutaneous Pulsed Electrical Stimulation (Device: WL-2103A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start30 Apr 2025 (estimated)
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928441
- Sponsor's protocol ID
- REB24-1438
- Status last verified
- Apr 2025
- First submitted
- 1 Apr 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Vagus Nerve Stimulation and Sleep in Healthy Volunteers: a Randomized Trial.
- ClinicalTrials.gov ID
- NCT06928441
- Acronym / sponsor ID
- REB24-1438
- Conditions
- Sleep
- Keywords
- Neuromodulation, Vagus nerve
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada
- Study start
- 30 Apr 2025 (estimated)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 15 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this study is to determine whether a 30-minute stimulation of the vagus nerve at the site of the tragus area of the outer ear, helps to improve sleep efficiency in healthy participants. The vagus nerve protects the heart and vital organs, by feeding back information to the brain, and subsequently mounting a protective response. The aim is to identify any potential benefits of a device to boost function of the vagus nerve.
The battery-operated portable electro-stimulator (sham, or active) (Transcutaneous auricular vagal nerve stimulation) is designed to be attached to the outer ear. The Transcutaneous Electrical Nerve Stimulator (TENS) (Model WL-2103A): 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 micro-sec. 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. It has been shown that a decrease in sympathetic activity and increase of parasympathetic modulation of the heart (controlled by the vagus nerve) creates the transition from wake to sleep states. Thus, stimulating the vagus nerve may maintain a balance of the autonomic nervous system and therefore, affect the quality of sleep.
The self-instrumented sleep evaluation device is a polysomnography (PSG) level 2 + ECG Prodigy Sleep System consisting of a chest mounted unit (CMU) that records heart-rate (ECG), breathing-rate (nasal cannula), chest and stomach movements, and leg movements. The head mounted unit (HMU) measures electroencephalogram (EEG) of the frontal lobe, eye and chin movements. The wrist unit records blood oxygen saturation (SpO2) and pulse rate. All the wearable devices sends the specific data to the table-top tablet (TTU) via Bluetooth. The system uses secured web-based PSG to analyze the EEG, electrooculogram (EOC), ECG, electromyogram, accelerometry, acoustic signals, nasal airflow, thoracic and abdomen respiratory effect, pulse rate and oxy-hemoglobin saturation. All results are scored using Michele Sleep Scoring System to create necessary files showing all the stages of sleep (N1, N2, N3, REM) including sleep length, desaturation and efficiency.
40-50 Participants will be asked to attend five study visits over a 1-2 month period:
- Laboratory visit 1: Informed consent, screening (~ 1 hour)
- Laboratory visit 2: Assessment of neuromodulation stimulation level using the lab stimulation device and demonstration of how-to self-instrument the Cerebra Sleep monitoring kit at their personal residence for 4 nights consecutively. Participants will be assigned to either a sham, or active stim device to self-administer and given the sleep questionnaires for each night. (~ 2 hours)
- Laboratory visit 3: Return the equipment and questionnaires and de-brief on the past 4 nights (~ 30 mins)
- Laboratory visit 4: (after 21-day washout period): Re-assessment of neuromodulation stimulation level and re-issue of a sleep kit. (~ 2 hours)
- Laboratory visit 5: Return the equipment and debrief on the past 4 nights. (~30 mins)
During the laboratory visits, participants will be trained on how to complete a full self-instrumentation using the sleep unit. For the ear neuro-stimulator, participants will respond to the tester's prompts as they experience increases in the level of stimulation. Participants will then be chosen at random to receive either the 30 minutes of outer ear stimulation, or no stimulation since the final setting of the neuro-stimulator will not be observable.
The analysis will be conducted using a two-tailed, two sample t-test on the first intervention to determine there were no significant differences within the 2 groups (sham, or active). T-test for differences between the two groups.
All the sleep data will be encrypted and transferred to a secure database and all hard copied data will be separated from identifiers into a locked file storage system.
Once the study is finished, the participants will have the option to view individual results.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trial Arm 1 | Experimental | Device: Transcutaneous Pulsed Electrical Stimulation (Device: WL-2103A)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. |
| Trial Arm 2 | Experimental | Device: Transcutaneous Pulsed Electrical Stimulation (Device: WL-2103A)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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Pulsed Electrical Stimulation (Device: WL-2103A)Also: Transcutaneous auricular vagal nerve stimulator, Transcutaneous Electrical Nerve StimulatorThe 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. | Device | Trial Arm 1, Trial Arm 2 |
Primary outcome
Change in Sleep Quality Evaluated by Polysomnography
Time frame: 4 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Pulsed Electrical Stimulation (Device: WL-2103A) in people with Sleep, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc J Poulin, PhD, DPhil, FPhysiol (1-403-220-8372, poulin@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sleep Quality Evaluated by Polysomnography (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.