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

Not yet recruitingOBSERVATIONAL
Enrollment

115

Participants

Timeline

Start Date

October 23, 2025

Primary Completion Date

October 23, 2026

Study Completion Date

October 23, 2026

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)

Trial Locations (2)

20814

Walter Reed National Military Medical Center, Bethesda

60611

Northwestern University Feinberg School of Medicine, Chicago

All Listed Sponsors
collaborator

Tufts University

OTHER

collaborator

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

UNKNOWN

collaborator

Walter Reed National Military Medical Center

FED

collaborator

Uniformed Services University of the Health Sciences

FED

collaborator

Henry M. Jackson Foundation for the Advancement of Military Medicine

OTHER

lead

Northwestern University

OTHER

NCT06994988 - ARPA-H Smart Band-Aid to Measure Chronic Pain in Women | Biotech Hunter | Biotech Hunter