Home-based ear (taVNS) stimulation for IBS pain

Home-Based Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Pain and Symptom Management Among Young Adults With Irritable Bowel Syndrome (IBS)

This trial will test whether a home-based ear vagus nerve stimulation device, used twice daily for six weeks, helps reduce pain and symptoms in 18–29-year-olds with IBS compared with a look‑alike sham device.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 29 Years
• Sex: All
• Sponsor: Yale University (Academic / other)
• Locations: 1 site (New Haven, Connecticut)
• Trial ID: NCT06847360 on ClinicalTrials.gov

What this trial studies

This is a pilot randomized, parallel two‑arm trial enrolling 80 young adults (18–29) with provider‑confirmed Rome IV IBS and recurring moderate pain. After a two‑week baseline run‑in, participants are randomized to Active or Sham transcutaneous auricular vagus nerve stimulation (taVNS) delivered at home twice daily for 30 minutes over six weeks, with in‑person setup and end‑of‑treatment visits and a further six‑week follow‑up. Investigators will measure feasibility (recruitment, adherence, barriers), safety, satisfaction, and patient‑reported pain and symptom outcomes. The intervention is delivered alongside usual care and self‑management education to capture real‑world acceptability and implementation issues.

Who should consider this trial

Good fit: Ideal candidates are 18–29-year-olds with a healthcare provider–confirmed diagnosis of IBS (Rome IV), who report moderate pain (≥3/10 at least four days a week), have internet access, and can attend in-person setup and final visits.

Not a fit: Patients with other chronic pain conditions, inflammatory bowel disease or celiac disease, diabetes, recent antibiotic or probiotic use, regular opioid or illicit substance use, pregnancy or lactation, severe recent psychiatric illness, or contraindications to taVNS are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this could offer a non-drug, home-based option to reduce IBS pain and improve symptom management for young adults.

How similar studies have performed: Small studies of taVNS have shown promise for modulating pain and autonomic function, but home-based taVNS for IBS symptoms is relatively novel and not yet proven.

Eligibility criteria

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;
* Diabetes mellitus;
* severe psychiatric condition requiring inpatient treatment in previous 6 months;
* Pregnancy or lactation;
* Regular use of opioids or other illicit substances;
* use of probiotics or antibiotics within 2 weeks from enrollment; and
* any other conditions/contraindications that prohibit the application of taVNS including but not limited to any current or past history of cardiovascular disorders, recent ear trauma, and metal implants above the level of the neck.

Where this trial is running

New Haven, Connecticut

• Yale University — New Haven, Connecticut, United States (Recruiting)

Study contacts

• Principal investigator: Xiaomei S Cong — Yale University
• Study coordinator: Xiaomei S Cong, PhD

Conditions Pain, Chronic; Irritable Bowel Syndrome; Symptom Cluster