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NCT06994988 · ClinicalTrials.gov registry record
ARPA-H Smart Band-Aid to Measure Chronic Pain in Women
A clinical trial, sponsored by Northwestern University.
- Recruiting
- Registry status
- 115
- Enrollment target
NCT06994988: Recruiting study, sponsored by Northwestern University.
NCT06994988 is a clinical trial that is actively recruiting participants, run by Northwestern University. The registered enrollment target is 115 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06994988 is actively recruiting participants, sponsored by Northwestern University.
- RECRUITING
- Registry status
- 115 participants
- Enrollment target
Study 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
Primary Outcome
We will measure the difference between the patient-reported pain scores and AI-generated objective pain score in subgroups of chronic pain patients (e.g., nociplastic pain, neuropathic pain, nociceptive pain, mixed pain) and healthy controls (if they have acute pain).
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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2026-07-01 |
| Est. Completion | 2027-04-23 |
What NCT06994988 shows while recruiting
NCT06994988 is an observational study that tracks outcomes without assigning an intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 3 interventions - of which A-Band (Smart Band-Aid) is the first listed.
NCT06994988 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06994988 about?
NCT06994988 is a clinical study titled "ARPA-H Smart Band-Aid to Measure Chronic Pain in Women". 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 ...
What is the current status of trial NCT06994988?
This trial is currently recruiting. The enrollment target is 115 participants. The study started on 2026-07-01. Estimated completion is 2027-04-23.
What interventions are being tested in trial NCT06994988?
The interventions under investigation include: A-Band (Smart Band-Aid) (DEVICE), Empatica Smartwatch (COMBINATION_PRODUCT), Questionnaires: Hospital Anxiety & Depression Scale, Central Sensitization Inventory, Pain Catastrophizing Scale, Somatic Symptom Scale-8, Pain Self-Efficacy Questionnaire-10, Athens Insomnia Scale (BEHAVIORAL).
Who is sponsoring clinical trial NCT06994988?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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