NCT06696339进行中（未招募）不适用
Collection of Fingertip Video for Determination of Heart Rate
PreemptiveAI, Inc1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年10月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Heart Rate Error
研究概览
简要总结
The goal of this clinical trial is to assess the accuracy of the PreemptiveAI SDK to measure heart rate for adults as compared to an FDA-approved ground truth device.
Participants will:
- Complete a demographics and health history survey
- Apply and wear ground truth equipment such as a pulse oximeter and ECG
- Measure their heart rate 8 times with 4 different smartphones using the PreemptiveAI SDK
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •Adults with both normal and abnormal heart rates
排除标准
- •Under 18 years of age
- •Unable to speak and read English
- •Deemed not suitable to participate by Investigator due to cognitive impairment, acute illness, or serious physical or mental health condition
- •Essential tremor in left or right hand
- •Raynaud's disease
- •Severe calluses on left or right index finger
- •Unable to produce a heart rate measurement due to low signal quality during the training phase (i.e. low perfusion, unable to hold hand steady, etc)
结局指标
主要结局
Heart Rate Error
时间窗: At single site visit, measured across 8 repetitions within a 1-hour period
Root mean square error of heart rate compared to ground truth device
次要结局
未报告次要终点
研究者
研究点 (1)
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