Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-27 @ 6:02 AM
Study NCT ID:
NCT06847360
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-31
First Post:
2025-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Home-based Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for IBS Pain
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
Home-Based Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Pain and Symptom Management Among Young Adults With Irritable Bowel Syndrome (IBS)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IBS-taVNS
Brief 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.
* 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.
Detailed 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 self-management education and their usual treatment and care. After enrollment and a 2-week baseline run-in period, participants will be randomized to the Active or Sham taVNS with a 6-week treatment (30 minutes per session, twice daily for 6 weeks) and be followed up for another 6 weeks of post-treatment. Investigators will assess feasibility through recruitment rates, adherence, factors influencing adherence, safety, satisfaction, and collection of patient-reported outcomes.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R34AT012917-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |