Not yet recruitingNAINTERVENTIONAL

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

This study aims to discover if a gentle electrical stimulation of a special nerve, called the vagus nerve, can help healthy people sleep better. You'll receive a small, battery-operated device that attaches to your outer ear for 30 minutes. Researchers want to see if this stimulation can improve your sleep quality and how you feel during your daily life. You'll visit a lab twice, a few weeks apart. During these visits, you'll learn how to set up the device and a sleep tracking kit at home. Sleep results from the two sessions (one with stimulation, one without) will be carefully compared to understand any effects on sleep.

At a glance

Status

Not yet recruiting

Phase

Sponsor

University of Calgary

Enrolment target

Start

30 Apr 2025

Estimated completion

30 Apr 2029

Sleep

What is this study about?

This research is looking into a new way to potentially improve sleep using a small, gentle electrical device. The device targets a specific nerve in your body called the vagus nerve, which plays an important role in how your body relaxes and transitions from being awake to sleeping. By sending small electrical pulses to this nerve through your outer ear, the study hopes to find out if it can help maintain a better balance in your body's systems, leading to more restful sleep.

Taking part in this study means you'll be one of the healthy volunteers who will receive this special ear stimulation. The device is small, battery-operated, and you can control how strong the stimulation feels. Although the device sends electrical impulses, it's designed to be gentle. Researchers believe that by stimulating the vagus nerve, it might help your body shift into sleep more effectively. Your sleep will be carefully monitored using a special sleep tracking kit at home.

The main goal is to compare your sleep when you use the device to when you don't use it. This will help the researchers understand if this ear stimulation could be a helpful tool for improving sleep efficiency and overall daily well-being for people. They'll be looking for any potential benefits this device might have.

Key takeaways

The study explores if gentle ear stimulation can improve sleep in healthy people.
A small, battery-operated device targets the vagus nerve on the outer ear.
Participation involves two lab visits and home sleep monitoring with a special kit.
You're randomly assigned to receive stimulation or a non-active device.
Your sleep quality will be compared between sessions to assess any benefits.
You can withdraw from the study at any time.

Who may be eligible?

You might be able to take part in this study if you are a healthy man or woman between 18 and 50 years old. You should be generally well and able to follow study instructions, including being comfortable using a small device attached to your ears for 30 minutes.

There are certain reasons why you wouldn't be able to join. For example, if you have a known history of conditions like heart, lung, kidney, or liver disease, asthma, or sleep apnea. Also, if you have diabetes, are a smoker, or if you are pregnant or breastfeeding, you unfortunately can't participate. Your blood pressure and heart rate will also be checked to make sure they are within a healthy range for the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 50 years old?
Are you generally healthy with no major medical conditions?
Are you able to use a small electric device on your ear for 30 minutes?
Can you comfortably breathe through your nose and wear a sleep tracker?
Are you not pregnant or breastfeeding?
Do you not have diabetes, asthma, or sleep apnea?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll visit the lab twice, about three weeks apart. During these visits, you'll receive detailed instructions on how to set up the ear stimulation device and a special sleep kit in your home. You'll use the ear device for 30 minutes at a time. The study will monitor your sleep using a special sleep tracking device. There are no regular clinic visits beyond the initial two, as the monitoring takes place at home. The total duration of your active participation will involve these two lab visits and the home monitoring period between them.

Potential risks and benefits

You might not get any direct benefit from taking part, but your contribution will help researchers understand if this device could improve sleep for others in the future. Potential risks or side effects from the gentle electrical stimulation are expected to be very mild, such as slight skin irritation at the ear where the device is placed. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Unviersity of Calgary
Verified postcode
Calgary, Canada

Common questions

What is the vagus nerve?

The vagus nerve is an important nerve that helps control many of your body's functions, including how you relax and prepare for sleep.

What does 'non-invasive stimulation' mean?

It means the treatment doesn't involve surgery or needles. The device will simply sit on the outside of your ear.

Will I feel anything when the device is on?

Yes, you might feel a gentle tingling sensation from the electrical pulses. You can adjust the intensity to what feels comfortable for you.

How will my sleep be measured?

You'll use a special sleep tracking device at home (called PSG) that records different aspects of your sleep, similar to what's used in sleep clinics.

Do I have to do anything else besides use the device?

You'll also need to be able to comfortably breathe through your nose and wear the sleep monitoring device, as instructed by the researchers.

How to find out more

Marc J Poulin, PhD, DPhil, FPhysiol

poulin@ucalgary.ca 1-403-220-8372 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.