Wearable biosignal measure for abdominal pain in people with IBS
Official title: OIME - Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain
Run by University of Connecticut · NCT06381921 · Data updated 2026-11-12
This trial will see if a wearable biosignal index from EDA, ECG, and EMG can measure belly pain and track treatment response in adults with IBS.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | University of Connecticut Academic / other |
| Locations | 1 site (Storrs, Connecticut) |
| Status | Recruiting |
| Started | September 8, 2025 |
| Main results expected | October 31, 2027 |
| Study ends | February 28, 2029 |
| Registry record updated | September 15, 2025 |
| Trial ID | NCT06381921 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–50 with a clinician diagnosis of IBS by Rome III or IV criteria who currently report abdominal pain, can read and speak English, and have daily access to a computer and the internet.
✕Probably not a fit
People outside the 18–50 range or with excluded conditions such as other chronic non-IBS pain disorders, celiac disease or inflammatory bowel disease, diabetes, serious mental health conditions, regular opioid or illicit drug use, or who are pregnant/recently postpartum are not eligible and would not benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The study collects telemetric biosignals (electrodermal activity, ECG, and EMG) from both healthy controls and people with IBS while they experience cutaneous and visceral pain to train a machine learning model that produces an Objective Integrated Multimodal Electrophysiological (OIME) index. In the first part, autonomic and muscular activity data are paired with reported visceral pain to build and train the OIME model. In the second part, an ambulatory trial in IBS participants uses the wearable system to validate the OIME index as a biomarker and to monitor pain changes during the IBS-PPSM intervention. Data collection is remote/ambulatory with site coordination at the University of Connecticut.
Why it matters
Potential benefit: If successful, this could provide an objective, wearable way to measure abdominal pain and help personalize and monitor treatment for people with IBS.
How similar studies have gone: Related work using wearable biosignals and machine learning for pain has shown promising but mixed results, and an integrated OIME biomarker for visceral pain is relatively novel and not yet established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants need to be diagnosed with IBS by a healthcare provider according to Rome-III or -IV criteria, with a current report of abdominal pain. * Men and women 18-50 years old * Able to read and speak English * Daily access to a computer with internet access. Exclusion Criteria: * Other chronic pains that are usually not comorbid with IBS, e.g., diabetic neuropathy, myofascial pain, low back pain, peripheral neuropathy etc. * Celiac disease or inflammatory bowel disease * Diabetes mellitus; d) Serious mental health conditions * Women during pregnancy or within 3 months post-partum period * Self- reported Regular use of opioids or other illicit substances. * Participants who have had COVID-19 should be fully recovered, and will be asked if their medical provider has made any restriction on activities.
Where it's running
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Vernon Cottage, Depot Campus
Storrs, Connecticut, United States Recruiting
Study contacts
- Study coordinator: Hugo F Posada-Quintero
- Email: hugo.posada-quintero@uconn.edu
- Phone: 8604861556
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.