Clinical Validation of the Norbert Health Device for Pulse Rate Measurement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Primary Objective
研究概览
简要总结
The study will evaluate the measuring pulse rate (PR) using the Norbert Device (ND) as compared to a reference heart rate measured using an electrocardiogram (ECG).
详细描述
The study design is to validate the pulse rate accuracy. The study is a non-randomized, non-blinded single arm design to evaluate the clinical accuracy of the ND's pulse rate measurement compared to a reference heart rate manually measured by observing R-peaks in a standard concurrently recorded ECG from an FDA 510(k)-cleared reference clinical ECG (RCECG). The sponsor will ensure that the study staff enrolls a range of subjects.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- •Subjects must be 18 years or older
- •Ability to comprehend written consent and provide informed consent
- •Ability to commit to and complete study related paperwork and activities (i.e. subject forms, have de-identified pictures taken, comply with periods of no movement, etc.)
排除标准
- •Pregnant women
- •Diagnosis of essential tremor or any medical condition causing tremors of the head or hands
- •Facial tattoos, scars, large moles, beards/hair growth, birthmarks, vitiligo, skin conditions, facial discoloration, or heavy makeup within the areas of interest
- •Inability for subject to avoid extreme movement during measurement reading windows
- •Inability for subject to raise their hand during measurement reading windows
- •No heart arrythmias
- •Discretion of the Principal investigator or clinical study staff
结局指标
主要结局
Primary Objective
时间窗: Approximately 1 hour
To validate the accuracy specification for pulse rate from the ND when compared to an FDA-cleared medical device for heart rate monitoring electrocardiogram (ECG monitor, 5 lead).
次要结局
未报告次要终点