Spire Medical Health Tag Actigraphy and Sleep Validation in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Spire, Inc.
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Evaluate the performance of the HT's step algorithm at different walking speeds.
研究概览
简要总结
The purpose of this study is to collect data to validate the step- (actigraphy) and sleep-tracking performance of the Medical Health Tag device developed by Spire Health.
详细描述
The purpose of this study is to collect data to validate the step- (actigraphy) and sleep-tracking performance of the Medical Health Tag device developed by Spire Health. The step data will be evaluated in a controlled environment over a range of approximately 1.0-2.5 miles per hour (i.e., slow to moderate walking) via Reference manual counting and pedometer. The sleep data will be evaluated in a natural environment (i.e., the participant's daily life and home) over one afternoon and night with Reference sleep/wake data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must have the ability to understand and provide written informed consent Subject is over 18 years of age Subject must be willing and able to comply with study procedures and duration Subject is a non-smoker Male or female of any race
排除标准
- •Subject is considered as being morbidly obese (defined as BMI >39.5)
- •Any medical condition that may prevent successful completion of the tasks in a healthy manner.
- •those requiring a wheelchair or who are housebound (haven't left their home without assistance in the last week)
- •Sleep disorder
- •Gait issue
- •Subjects with known respiratory conditions such as severe asthma, flu, bronchitis, or shortness of breath.
- •Subjects with self-reported heart or cardiovascular conditions such as congestive heart failure (CHF) or history of stroke or heart attack.
- •Any neurological condition such as Parkinson's, Alzheimer's, and Epilepsy
- •Subjects experiencing significant sleep impairment or sleep disturbances
- •Those with insufficient English language skills to either fully evaluate their understanding of these exclusion criteria during screening or that would otherwise impair their ability to fully participate
- •Pregnant at the time of the study
- •Unwilling to commit, in writing, to:
- •be on-time for the study
- •be on-time returning the devices the following day
- •avoid alcohol or intoxicants before and during the study
结局指标
主要结局
Evaluate the performance of the HT's step algorithm at different walking speeds.
时间窗: One day
Accuracy of the Medical Health Tag for the measurement of steps to the Reference
Evaluate the performance of the HT's sleep algorithm accuracy in classifying sleep and wake.
时间窗: One day
Accuracy of the HT for the measurement of 60 seconds sleep epochs and total sleep time
次要结局
未报告次要终点