Early-feasibility Study to Evaluate Usability and Safety of the Watch-Transcutaneous Electrical Acustimulation (TEA) Device
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Usability of the device for both groups day 3
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Watch-TEA
干预措施: Watch-TEA group (Device)
Watch-TEA
干预措施: Tethered TEA device (Device)
Tethered TEA device
干预措施: Tethered TEA device (Device)
Tethered TEA device
干预措施: Watch-TEA group (Device)
结局指标
主要结局
Usability of the device for both groups day 3
时间窗: 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.
Number of adverse events related to the device noted on the safety questionnaire
时间窗: 1-2 weeks (after baseline visit 1)
A safety questionnaire with 3 questions about skin irritation, pain, or infection. Visit 2 is at 1-2 weeks after visit 1.
Number of Transcutaneous Electrical Acustimulation (TEA)-related adverse events for both groups 3 days
时间窗: Day 3
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
Number of TEA-related adverse events for both groups 60 minutes at maximal tolerable level
时间窗: Daily for 3 days
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
Number of adverse events related to the device noted on the safety questionnaire
时间窗: 1-2 weeks (after baseline visit 1)
A safety questionnaire with 3 questions about skin irritation, pain, or infection. Visit 2 is at 1-2 weeks after visit 1.
Usability of the device for both groups day 3
时间窗: 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.
Number of Transcutaneous Electrical Acustimulation (TEA)-related adverse events for both groups 3 days
时间窗: Day 3
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
Number of TEA-related adverse events for both groups 60 minutes at maximal tolerable level
时间窗: Daily for 3 days
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
Number of non-treatment TEA adverse events for both groups
时间窗: up to 1-2 weeks (after baseline visit 1)
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
次要结局
未报告次要终点
研究者
Jiande Chen
Professor of Internal Medicine
University of Michigan