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

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

Conditions

• Chronic Pain

Interventions

DEVICE

A-Band (Smart Band-Aid)

The A-Band is a smart band-aid placed on the forearm or other designated site that collects interstitial fluid (ISF) from participants using a microneedle patch. ISF is a natural fluid found between your cells that can inform us on your bodily readings and health. A microneedle patch is a safe alternative to standard fluid collection which uses tiny needles to collect the ISF. The patches consist of single-use, sterile (clean) microneedles created from biocompatible materials. These microneedles penetrate the outermost skin layer without causing significant discomfort, pain, or bleeding.

COMBINATION_PRODUCT

Empatica Smartwatch

A commercial smart band will be worn by participants for 22+ hours a day for approximately 7 days. The smart band collects biophysical data from the participant. This includes data on biomarkers, heart rate and heart rate variability, galvanic skin response, step count, and temperature fluctuations, among other biophysical data.

BEHAVIORAL

Questionnaires: Hospital Anxiety & Depression Scale, Central Sensitization Inventory, Pain Catastrophizing Scale, Somatic Symptom Scale-8, Pain Self-Efficacy Questionnaire-10, Athens Insomnia Scale

HADS- measures anxiety and depression (0-21, higher scores signify greater pathology); CSI- measures central sensitization (0-100, higher scores signify greater central sensitization, PCS- measures catastrophizing (0-52, higher scores signify greater catastrophization), SSS-8- measures somatization (0-32, higher scores signify greater somatization), PSEQ-10- measures self-efficacy (0-60, with lower scores signifying low self-efficacy), AIS- measures sleep (0-28, with higher scores signifying greater sleep dysfunction)

Sponsors & Collaborators

• Tufts University

  collaborator OTHER

• The Advanced Research Projects Agency for Health (ARPA-H)

  collaborator UNKNOWN

• Walter Reed National Military Medical Center

  collaborator FED

• Uniformed Services University of the Health Sciences

  collaborator FED

• Henry M. Jackson Foundation for the Advancement of Military Medicine

  collaborator OTHER

• Northwestern University

  lead OTHER

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-05-01

Primary Completion

2027-04-23

Completion

2027-04-23

FDA Device

Yes

Countries

• United States

Study Locations