Clinical Trial

ARPA-H Smart Band-Aid to Measure Chronic Pain in Women

Recruiting
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Summary
The goal of this clinical trial is to test whether a minimally invasive microneedle patch, called the A-Band (Smart Band-aid), worn on the arm (monitoring key biomarkers in interstitial fluid) and a commercial smartwatch can accurately correlate with self-reported pain in women with chronic pain. A secondary purpose of the study is to identify demographic and clinical variables impacting pain measurement. The main questions that this study aims to answer are: * What is the correlation between AI-adjusted pain scores, based on biomarkers and validated tools, and self-reported pain scores? * What influence do demographic and clinical information have in the correlation of these pain scores? Researchers will compare data from these tools with self-reported pain scores in women with chronic pain and healthy women. Participants will: * Be a part of the study for approximately 8 days * Attend 2-3 in-person visits at the applicable clinical center over approximately one week * Wear a Smart Band-Aid (A-Band) at least twice per day for a week, with each application lasting up to 90 minutes * Complete questionnaires regarding medical history, pain information, mental health, sleep, and demographic data * Record daily pain scores * Wear a smartwatch for one week which will collect biophysical data (heart rate, skin response, etc.) * Collect daily saliva samples * Have blood drawn by medical staff at 2 in-person visits
Protocol Amendment History 1 change
critical Recruitment opened 2026-06-16
Trial Details
NCT Number NCT06994988
Lead Sponsor Northwestern University
Collaborators: Tufts University, The Advanced Research Projects Agency for Health (ARPA-H), Walter Reed National Military Medical Center, Uniformed Services University of the Health Sciences, Henry M. Jackson Foundation for the Advancement of Military Medicine
Conditions Chronic Pain
Enrollment 115 participants
Start Date 2026-07-01
Primary Completion 2027-04-23 (estimated)
Study Completion 2027-04-23 (estimated)
Updated on ClinicalTrials.gov 2026-06-15