Clinical trial NCT06366074: Early-feasibility Study to Evaluate Usability and Safety of the Watch-Transcutaneous Electrical Acustimulation (TEA) Device
Official title: Early-feasibility Study to Evaluate Usability and Safety of the Watch-Transcutaneous Electrical Acustimulation (TEA) Device
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Usability
Early feasibility
Safety
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Transtimulation Research, Inc
First posted: 2024-04-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Prevalence of delayed Chemotherapy-induced nausea, emesis, and dyspeptic symptoms (CINEDS) is 75% in women vs 51% in men (60% to 40% ratio). Therefore, every effort will be made to recruit at least 60% female subjects into the clinical study.
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Participants that are willing and able to come to the clinic for two scheduled visits
* Participants are capable of understanding clinical study procedures
* Participants agree to complete the questionnaires

Exclusion Criteria:

* Participants with implanted medical devices for electrical stimulation (e.g. cardiac pacemaker)
* Those enrolled in a concurrent clinical study
* Those unable to comply with the study protocol due to a disease, psychiatric illness, alcoholism, substance abuse, geographic distance, or other factors that would place the study participant at increased risk or preclude the study participant's full compliance with or completion of the study

Primary outcomes:
measure: Usability of the device for both groups day 3
timeFrame: Day 3
measure: Number of adverse events related to the device noted on the safety questionnaire
timeFrame: 1-2 weeks (after baseline visit 1)
measure: Number of Transcutaneous Electrical Acustimulation (TEA)-related adverse events for both groups 3 days
timeFrame: Day 3
measure: Number of TEA-related adverse events for both groups 60 minutes at maximal tolerable level
timeFrame: Daily for 3 days
measure: Number of non-treatment TEA adverse events for both groups
timeFrame: up to 1-2 weeks (after baseline visit 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Jiande Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References: