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 groupsSponsors 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