Actively Recruiting

Phase Not Applicable
Age: 18Years - 29Years
All Genders
NCT06847360

Home-based Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for IBS Pain

Led by Yale University · Updated on 2026-04-13

80

Participants Needed

1

Research Sites

101 weeks

Total Duration

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Sponsors

Y

Yale University

Lead Sponsor

F

Florida State University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Home-based Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for IBS Pain

Who Can Participate

Age: 18Years - 29Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 to 29 years of age
  • Men and women
  • Diagnosis of IBS by a healthcare provider with current pain
  • Moderate pain (3 or higher on numeric rating scale) at least 4 days per week for past 3 months
  • Daily access to a computer with internet
  • Able to read and speak English
Not Eligible

You will not qualify if you...

  • Other chronic pain conditions
  • Celiac disease or inflammatory bowel disease
  • Diabetes mellitus
  • Severe psychiatric condition requiring inpatient treatment in past 6 months
  • Pregnancy or lactation
  • Regular use of opioids or illicit substances
  • Use of probiotics or antibiotics within 2 weeks before enrollment
  • Conditions preventing taVNS use, including cardiovascular disorders, recent ear trauma, or metal implants above the neck

AI-Screening

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Trial Site Locations

Total: 1 location

1

Yale University

New Haven, Connecticut, United States, 06511

Actively Recruiting

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Research Team

X

Xiaomei S Cong, PhD

CONTACT

J

Jie Chen, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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