ARPA-H Smart Band-Aid to Measure Chronic Pain in Women
RecruitingNCT06994988
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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
Study details
- Official title
- Multi-modal Smart Band-Aid for AI-based Quantification of Pain
- Conditions
- Interventions
- Device: A-Band (Smart Band-Aid)
- Combination product: Empatica Smartwatch
- Behavioral: Questionnaires: Hospital Anxiety & Depression Scale, Central Sensitization Inventory, Pain Catastrophizing Scale, Somatic Symptom Scale-8, Pain Self-Efficacy Questionnaire-10, Athens Insomnia Scale
- Sponsor
- Northwestern University
- Collaborators
- Tufts University; 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
- Start date
- 2026-07-06
- Primary completion
- 2027-04-23
- Sex
- Female
- Age range
- from 18 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: For chronic pain group: * Female, 18 years or older. * Diagnosis of chronic pain condition (e.g., fibromyalgia, chronic lower back pain) as determined by the Principal Investigator. * Ability to provide informed consent. For healthy controls: * Female, 18 years or older. * No history of chronic pain. * No significant or poorly controlled medical conditions as determined by the Principal Investigator and exclusion criteria. * No significant active, poorly controlled psychological conditions as determined by the Principal Investigator and exclusion criteria. * Ability to provide informed consent. Exclusion Criteria (both groups): * Pregnant or breastfeeding women. * Substance abuse or psychiatric disorders that interfere with study participation. * Major medical conditions (such as severe cardiovascular, neurological, cancer or autoimmune diseases) or psychological conditions (e.g., active, poorly-controlled depression, anxiety disorder, PTSD, substance use disorder) that interfere with study participation. * Possibility of secondary financial gain from participation * Interventional pain treatment(s) within 6 weeks of baseline (injection, epidural, etc.) * Current opioid usage or usage within 2 weeks of baseline
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06994988