Irritable Bowel Syndrome (IBS) Clinical Trials

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Home-Based Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Pain and Symptom Management Among Young Adults With Irritable Bowel Syndrome (IBS)

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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: * 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 29
Healthy Volunteers: f
View:

• 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.

Locations
United States
Connecticut
Yale University
RECRUITING
New Haven
Contact Information
Primary
Xiaomei S Cong, PhD
xiaomei.cong@yale.edu
8606179849
Backup
Jie Chen, PhD
jc22db@fsu.edu
850-645-0657
Time Frame
Start Date: 2026-01-19
Estimated Completion Date: 2028-01
Participants
Target number of participants: 80
Treatments
Experimental: Active taVNS intervention
Active taVNS twice daily, 30 minutes per session, over 6 weeks.
Sham_comparator: Sham taVNS
Sham taVNS twice daily, 30 minutes per session, over 6 weeks.
Sponsors
Collaborators: National Center for Complementary and Integrative Health (NCCIH), Florida State University, Rutgers University
Leads: Yale University

This content was sourced from clinicaltrials.gov