This project is being completed to test the usability and safety of the Watch-Transcutaneous Electrical Acustimulation (TEA) Device. This is a pilot study that will lead to future projects for cancer patients that may experience chemotherapy-induced symptoms.
This project will include three different aims (aim three is a clinical trial) and will be funded by the National Institute of Health (NIH). In aims 1 and 2 the device hardware and device application will be developed and will not be included in this registration as these are not clinical trials. However, aim three is being registered early in the project in order to obtain the Notice of Award (NOA) funding from the NIH. Once the NOA has been obtained the registration will be updated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Subjects will wear the device for 3 days. The subjects will self-apply the TEA for 60 min once daily with the current amplitude set at a maximal tolerable level. To increase the subject compliance, two measures will be implemented: timely alerts by the app (and phone calls, if needed) for performing the TEA sessions, and recording full history of therapy sessions on the device for monitoring the compliance.
Subjects will wear the device for 3 days. The subjects will self-apply the TEA for 60 min once daily with the current amplitude set at a maximal tolerable level. To increase the subject compliance, two measures will be implemented: timely alerts by the app (and phone calls, if needed) for performing the TEA sessions, and recording full history of therapy sessions on the device for monitoring the compliance.
University of Michigan
Ann Arbor, Michigan, United States
Usability of the device for both groups day 3
Questionnaires are administered online and there are 17 usability questions in the questionnaire. All answers use 0-to-5 scale (0 - no,1 - minor, 2 - some, 3 - considerable, 4 - major, 5 - critical) with a range of 0-85 with a higher score meaning more usable.
Time frame: Day 3
Number of adverse events related to the device noted on the safety questionnaire
A safety questionnaire with 3 questions about skin irritation, pain, or infection. Visit 2 is at 1-2 weeks after visit 1.
Time frame: 1-2 weeks (after baseline visit 1)
Number of Transcutaneous Electrical Acustimulation (TEA)-related adverse events for both groups 3 days
These will include skin irritation, pain, or infection under the Watch-TEA and tethered TEA devices after wearing each device for 3 consecutive days. Adverse events will be noted by the following: 1. \- Mild averse event (AE) - No treatment needed 2. \- Moderate AE - Resolved with treatment 3. \- Severe AE - Inability to carry on normal activities, required professional medical attention 4. \- Life-threatening or disabling AE 5. \- Fatal AE
Time frame: Day 3
Number of TEA-related adverse events for both groups 60 minutes at maximal tolerable level
The subjects will self-apply the TEA for 60 minutes once daily with the current amplitude set at a maximal tolerable level. Events collected will include skin irritation, pain, or infection. Adverse events will be noted by the following: 1. \- Mild AE - No treatment needed 2. \- Moderate AE - Resolved with treatment 3. \- Severe AE - Inability to carry on normal activities, required professional medical attention 4. \- Life-threatening or disabling AE 5. \- Fatal AE
Time frame: Daily for 3 days
Number of non-treatment TEA adverse events for both groups
Adverse events will be noted by the following: 1. \- Mild AE - No treatment needed 2. \- Moderate AE - Resolved with treatment 3. \- Severe AE - Inability to carry on normal activities, required professional medical attention 4. \- Life-threatening or disabling AE 5. \- Fatal AE
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Time frame: up to 1-2 weeks (after baseline visit 1)