A Single Center Study on the Functionality of the Pulse Oximeter and Accelerometer Portions of a Novel Wearable Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Mean Absolute Error of Dove Device Compared to FDA Approved SpO2 Sensor
研究概览
简要总结
The purpose of this study is to asses the function of an oxygen sensor and the movement sensor in a novel device prototype.
详细描述
After informing the patient about the study and the potential risk. The patient is asked to wear a prototype of a novel device to sense oxygen levels and movement for the duration of the visit. The day of the enrolment is when the visit will be completed. The patient is required to complete an overnight sleep test (no more than 15 hrs) with the prototype device worn on their index finger and wrist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and Females
- •21 years of age or older
- •Suspected to suffer from hypoxic events
- •Able to provide informed consent
排除标准
- 未提供
研究组 & 干预措施
Assess device prototype functionality
Everyone will be in the same arm
干预措施: FDA approved pulse oximeter and DOVE device prototype (Device)
结局指标
主要结局
Mean Absolute Error of Dove Device Compared to FDA Approved SpO2 Sensor
时间窗: 15 hours
Dove device will be analyzed against FDA approved SpO2 and Skin tone will be incorporated as a factor of SpO2 function to ensure the device can be reasonably detect hypoxia. At each time point, the difference between the device and the FDA approved standard will be calculated. Mean average error will be used as a single summary statistic, and Bland-Altmann analysis will be used to graphically and numerically represent the limits of agreement.
次要结局
- Questionnaire About Comfort of Device(15-20 minutes depending on the patients questions.)