Home-Based Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Pain and Symptom Management Among Young Adults With Irritable Bowel Syndrome (IBS)
Yale University
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.
Description
This pilot randomized controlled study aims to evaluate the feasibility, acceptability, adherence, safety, and potential implementation barriers of home-based taVNS intervention in YAs (18-29 years old) diagnosed with IBS. A two-site, two-arm, parallel, proof-of-concept randomized trial will be conducted to assess the feasibility of using the Active taVNS intervention compared with Sham taVNS in managing IBS-related pain and symptoms. Eighty YAs meeting the Rome IV diagnostic criteria of IBS will be recruited and receive either Active or Sham taVNS for pain and symptom management, along with s…
Eligibility
- Age range
- 18–29 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. Exclusion Criteria: * Other chronic pain condition; * Celiac disease or inflammatory bowel disease; * Diab…
Interventions
- DeviceHome-based taVNS intervention
Home-based taVNS intervention will be administered using the non-invasive taVNS device, Parasym system (Parasym Health, Inc, London, UK).
Location
- Yale UniversityNew Haven, Connecticut