NCT07217327招募中不适用
DistaSense: Two-Center Prospective, Non-Significant Risk (NSR) Study to Evaluate Heart Rate and Respiratory Rate Performance for Life Detection Technologies
Life Detection Technologies2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年8月13日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Accuracy and bias between the DistaSense measurements of heart rate and respiratory rate and the reference measurements
研究概览
简要总结
A prospective, non-significant risk study designed to validate the performance of the DistaSense Contactless Sensor and algorithm for detecting heart rate and respiratory rate, compared to gold standard reference technology.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 22 years
- •Fluent in English
- •Willing and cognitively able to provide informed consent
- •Expected by the investigator to achieve sufficient sleep duration for a minimum of 4 hours of meaningful data (e.g., absence of significant insomnia)
- •Able to complete the scripted portion of the evaluation
排除标准
- •Sufficiently broken, damaged or irritated skin or rashes near the sensor application sites such that investigator believes should be precluded from enrollment
- •Subjects with electronic implants of any kind (e.g. pacemaker)
- •Subjects that are Life Detection Technology employees or shareholders, or family of a Life Detection Technology employee or shareholder
结局指标
主要结局
Accuracy and bias between the DistaSense measurements of heart rate and respiratory rate and the reference measurements
时间窗: Day 1
次要结局
- Mean absolute relative difference for each of HR and RR between the DistaSense and the reference(Day 1)
- Deming regression for each of the HR and RR data(Day 1)
研究者
研究点 (2)
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