Ear nerve stimulation at home for pain in young adults with irritable bowel syndrome
Tests home ear nerve stimulation for pain in young adults with irritable bowel syndrome.
Key facts
- Who runs it
- Yale University
- Where
- New Haven, United StatesSee the site
- Trial code
- Registry title
- Home-based Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for IBS Pain
- Status
- Recruiting
- People taking part
- 80 people, planned
- Started
- 19 Jan 2026
- Expected to end
- Jan 2028
- Type of study
- Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
- Treatments tested
- Home-based taVNS intervention
- Record updated
- 13 April 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for young adults with irritable bowel syndrome (IBS) who have ongoing pain. They will use an ear nerve stimulation device (taVNS) at home for 6 weeks.
- Age
- 18 to 29 years
- Sex
- Men and women
- Disease stage
- IBS diagnosed by a healthcare provider (Rome IV criteria), with current pain. Pain must be moderate (≥3 out of 10) on at least 4 days a week for the previous three months.
- Earlier treatment
- No probiotics or antibiotics within 2 weeks before joining. No regular use of opioids.
Main reasons for not taking part
- Another chronic pain condition, celiac disease, inflammatory bowel disease or diabetes mellitus
- Severe mental health condition needing hospital treatment in the previous 6 months
- Pregnancy or breastfeeding
- Regular use of opioids or other illicit substances
- Conditions that rule out taVNS, such as current or past heart or blood vessel disorders, recent ear injury, or metal implants above the neck
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 18 - 29 years of age
- Men and women
- Diagnosis of IBS from a healthcare provider with current report of pain (volunteers asked to bring provider-verification of IBS diagnosis based on Rome IV criteria to initial study appointment)
- Experiencing moderate pain (≥3 out of 10 on numeric rating scale [NRS]) at least 4 days of the week and lasting previous three months
- Daily access to a computer connected to the internet; and
- Able to read and speak English
Who cannot take part
- severe psychiatric condition requiring inpatient treatment in previous 6 months
- Other chronic pain condition
- Celiac disease or inflammatory bowel disease
- Diabetes mellitus
- any other conditions/contraindications that prohibit the application of taVNS including but not limited to any current or past history of cardiovascular disorders, recent ear trauma, and metal implants above the level of the neck
- Pregnancy or lactation
- Regular use of opioids or other illicit substances
- use of probiotics or antibiotics within 2 weeks from enrollment; and
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 29 years old?
Where in United States
- Yale UniversityNew Haven, United StatesContact: Xiaomei S Cong, PhDTaking people
About the trial
What the trial wants to find out
The goal of this clinical trial is to learn the feasibility and safety of using home-based taVNS in young adults with IBS to manage their IBS-related pain and symptoms. It will also learn about participants' experience in using the home-based taVNS intervention. The main questions it aims to answer are:
Read full original descriptionShow less
* Is it feasible to use a home-based taVNS intervention for pain and symptom management among YAs with IBS? * Is it safe and reported satisfactory to use a home-based taVNS intervention for pain and symptom management among YAs with IBS? Researchers will compare Active to Sham taVNS (a look-alike intervention that contains minimal stimulation) to see if Active taVNS works on managing IBS-related pain and symptoms.
Participants will:
* Take Active or Sham taVNS intervention for a 6-week treatment (twice daily, 30 minutes per session) * Visit the research lab at the initial setup and the end of the 6-week treatment for checkups and tests * Keep a diary of their symptoms and the number of times they use the taVNS.
The 2 groups in the trial
- Active taVNS interventionTreatment being tested
Active taVNS twice daily, 30 minutes per session, over 6 weeks.
Treatment: Home-based taVNS intervention
- Sham taVNSSham treatment, for comparison
Sham taVNS twice daily, 30 minutes per session, over 6 weeks.
Treatment: Home-based taVNS intervention
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Home-Based Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Pain and Symptom Management Among Young Adults With Irritable Bowel Syndrome (IBS)
- Plain-language title
- Ear nerve stimulation at home for pain in young adults with irritable bowel syndromeGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT06847360, who can take part
- Record updated
- 13 April 2026