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Official title Non-invasive Ultrasonic Auricular Vagus Nerve Stimulation
ClinicalTrials.gov ID: NCT07283913
What this study is testing
- What it's testing
- The Vagus nerve, one of 12 cranial nerves that connect the brain to the human body, controls specific involuntary functions such as breathing, heart rate, the digestive system and the immune system, and it is crucial to unlocking the relaxation response (parasympathetic nervous system). Vagus nerve stimulation (VNS) can be invasive or non-invasive, and both methods have been trialled in research studies.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Participant is willing and able to give informed consent for participation in the study
- Not currently taking any medications (except the contraceptive pill)
- Aged 18 or over
- Good general health
- Able and willing to remove any piercings in the left ear
You likely can't join if
- Current or past diagnosis of a major neurological, neurosurgical, or psychiatric disorder (including self-reported depression)
- Inability to complete informed consent process
- Personal history of cardiac arrhythmia
- Diabetes
- High blood pressure (\>140 mmHg systolic and/or \>90 mmHg diastolic)
- Other significant medical condition (including cardiological disorders; specific details to be reviewed by the CI prior to inclusion)
See the full eligibility criteria
- Participant is willing and able to give informed consent for participation in the study
- Not currently taking any medications (except the contraceptive pill)
- Aged 18 or over
- Good general health
- Able and willing to remove any piercings in the left ear
- Able to abstain from exercise and fast from food for 12 hours before the second and third visit
- Current or past diagnosis of a major neurological, neurosurgical, or psychiatric disorder (including self-reported depression)
- Inability to complete informed consent process
- Personal history of cardiac arrhythmia
- Diabetes
- High blood pressure (\>140 mmHg systolic and/or \>90 mmHg diastolic)
- Other significant medical condition (including cardiological disorders; specific details to be reviewed by the CI prior to inclusion)
- Use of medication or recreational drugs that affect the nervous system in the past 3 months
- Medication intake (such as beta-blockers, glucocorticoids, antidepressants, anti-inflammatory drugs) in the last 7 days - contraceptive medication in women is allowed
- Currently pregnant or breastfeeding
- Allergy to aquasonic gel or any of its components (propylene glycol, glycerin, isothiazolinones)
- Participation in a research study in the last 3 months involving invasive procedures or an inconvenience allowance (required for all UoN FMHS UREC-approved studies)
- BMI \ 30 kg/m²
- Excessive consumption of alcohol (\>2 alcoholic beverages/day) or tobacco (\>5 cigarettes/day)
- Previous experience with stress tests
- Known infection in the last 8 weeks
The study team makes the final eligibility decision.
Where it's taking place
- Nottingham, Nottinghamshire, United Kingdom
- Nottingham, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nottingham, Nottinghamshire, United Kingdom; Nottingham, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.