Status:
NOT_YET_RECRUITING
Non-invasive Vagus Nerve Stimulation and Sleep in Healthy Volunteers.
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Natural Sciences and Engineering Research Council, Canada
Conditions:
Sleep
Eligibility:
All Genders
18-50 years
Phase:
NA
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...
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....
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2029
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06928441
Start Date
April 30 2025
End Date
April 30 2029
Last Update
April 15 2025
Active Locations (1)
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1
Unviersity of Calgary
Calgary, Alberta, Canada, T2N 4N1