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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT06847360
Status
Recruiting
Apply to this trial

Conditions

  • Irritable Bowel Syndrome
  • Pain, Chronic
  • Symptom Cluster

Eligibility Criteria

Sex
ALL
Age
18 Years - 29 Years
Healthy Volunteers
Not accepted

Interventions

  • Home-based taVNS intervention — DEVICE
    Home-based taVNS intervention will be administered using the non-invasive taVNS device, Parasym system (Parasym Health, Inc, London, UK).

Study Details

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.

Key Dates

Start date
Jan 19, 2026
Status verified
Apr 2026
Primary completion
Sep 30, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active taVNS intervention
    Active taVNS twice daily, 30 minutes per session, over 6 weeks.
  • Sham Comparator: Sham taVNS
    Sham taVNS twice daily, 30 minutes per session, over 6 weeks.

Primary Outcome Measure

Feasibility of implementing taVNS - Retention rates [ Time Frame: Baseline, week 6, week 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06511
Xiaomei S Cong, PhD
Jie Chen, PhD
[email protected]
850-645-0657
Jie Chen, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New Haven, CT

By research site
Yale University· New Haven, CT

Related Studies