Home-based Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for IBS Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-29
SponsorYale University
About this trial
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 criteria
Qualifiers
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;
Disqualifiers
Other chronic pain condition;
Celiac disease or inflammatory bowel disease;
Diabetes mellitus;
severe psychiatric condition requiring inpatient treatment in previous 6 months;
Trial design
Treatments tested in this trial
- Home-based taVNS intervention
Treatment groups
80 Participants
are divided into 2 treatment groupsLocations
1Yale University06511, New HavenConnecticut, United States
Sponsors and collaborators
Yale University
Lead sponsor
Florida State University
Collaborator
Rutgers University
Collaborator
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Source ClinicalTrials.gov