OIME - Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain
Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The objectives of the study are to 1) Conduct telemetric biosignals (EDA, ECG, and EMG) recording in healthy controls and IBS participants experiencing cutaneous and visceral pain; and 2) Validate the OIME index as a biomarker for quantifying pain in IBS participants and its capability to assess the treatment of IBS pain via an ambulatory trial.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
View:
• 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.
Locations
United States
Connecticut
Vernon Cottage, Depot Campus
RECRUITING
Storrs
Contact Information
Primary
Hugo F Posada-Quintero
hugo.posada-quintero@uconn.edu
8604861556
Time Frame
Start Date: 2025-09-08
Estimated Completion Date: 2029-02-28
Participants
Target number of participants: 120
Treatments
Experimental: IBS-PPSM intervention group
After the baseline visit, the IBS-PPSM group will receive 10 video modules focused on IBS knowledge and self-management skills plus one-on-one consultation with a nurse for personalized advice about self-monitoring, diet, sleep, and goal setting. The IBS-PPSM group will be taught to use the abdominal belt/smart watch system for daily recording of bio-signals and voluntary report of episodes of visceral pain. We will follow up with all participants 4 weeks after enrollment, in a final lab visit, and measure primary outcomes to compare to the baseline data.
No_intervention: IBS-control group
The IBS-control group will not receive pain self-management intervention. Participants will be taught to use the abdominal belt/smart watch system for daily recording of bio-signals and voluntary report of episodes of visceral pain. We will follow up with all participants 4 weeks after enrollment, in a final lab visit, and measure primary outcomes to compare to the baseline data.
Related Therapeutic Areas
Sponsors
Collaborators: Yale University
Leads: University of Connecticut