Clinical Validation of the Dozee System for Contactless Monitoring of Heart Rate, Respiration Rate, Motion, and Bed-Exits
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Mean Absolute Error (MAE) of Dozee's Heart Rate a from the Gold Standard ECG
研究概览
简要总结
The Dozee VS system (K221555) is a contactless device that tracks heart rate and breathing rate using a sensor sheet placed under the mattress. It captures body vibrations and converts them into vital signs, which can be monitored remotely in real time. The system also supports add-ons like a blood pressure cuff, pulse oximeter, and thermometer, offering a complete monitoring solution. This study aims to validate the updated AI-powered heart rate and improved breathing rate algorithms across different sensor sheet types to confirm clinical accuracy
详细描述
The Dozee VS system (K221555), developed by Turtle Shell Technologies, is a non-invasive, contactless device that continuously monitors heart rate (HR) and breathing rate (RR). A thin sensor sheet placed under the mattress detects tiny body vibrations from the heart and lungs, which are processed by smart algorithms and displayed on a secure online dashboard for real-time monitoring.
Unlike traditional methods such as ECGs, nasal tubes, or thermistors-which are invasive, require skilled placement, and are uncomfortable for long-term use-Dozee is simple, comfortable, and doesn't rely on patient compliance like wearables do. The system can also connect to add-on devices, including a blood pressure cuff, pulse oximeter, and thermometer, giving a full picture of a patient's vital signs and helping spot early signs of deterioration.
Hardware upgrades now include dual-sensor sheets that improve accuracy across different mattresses and patient types. The new HR algorithm uses AI/ML for better accuracy, while the improved RR algorithm performs more reliably even with movement or weak signals.
Study Goal: This study aims to validate the updated algorithms (Gen 2) for HR and RR across the three sensor sheet types (DS, S1, and S1-I) to ensure they meet clinical accuracy standards
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects will be included if they meet the following inclusion criteria:
- •Adults Male or female. (Above 18 years of age)
- •Provide written informed consent.
- •Weight between 40kg/88.18lbs and 120kg/264.55lbs
- •Agree to not eat during the testing period
- •Able to move and exit the bed independently and safely.
排除标准
- •Subjects will be excluded if they have any of the following inclusion criteria:
- •Are connected to a device that may interfere with the device monitoring in this study.
- •Are receiving any bedside care which may be incompatible with the study procedures.
- •A likely need to receive or undergo a procedure during the testing period.
- •Cannot accept a nasal cannula, or have an ECG leads placed on the chest.
- •Have a significant medical condition in the judgement of the investigator, which may compromise the study testing procedures.
结局指标
主要结局
Mean Absolute Error (MAE) of Dozee's Heart Rate a from the Gold Standard ECG
时间窗: 6 months
Heart Rate collected at 1 Min intervals from gold standard and Dozee. Mean Absolute Error (MAE) of the Dozee Heart Rate will be calculated.
Accuracy (%) of Dozee in identfying subject movement
时间窗: 6 months
Time stamps of subject movement during the study will be recorded manullay. Time stamps of Dozee's movement will be recorded. Accuracy of the Dozee device in detecting movement compared to manual observation will be computed in terms of percentage.
Accuracy(%) of of Dozee's bed-exits
时间窗: 6 months
Time stamps of bed-exits will be recorded manually during the study will be recorded. Time stamps of Dozee's bed-exit will be computed. Accuracy of the Dozee device in detecting bed-exit compared to manual observation as gold standard will be computed in terms of percentage.
Mean Absolute Error (MAE) of Dozee's Respiratory Rate from the Gold Standard Capnography
时间窗: 6 Months
Respiratory Rate collected at 1 Min intervals from gold standard and Dozee. Mean Absolute Error (MAE) of the Dozee Respiratory Rate will be calculated.
次要结局
- Range of values (minimum, maximum, and spread) of Heart Rate in beats per min measured by the gold standard and the Dozee(6 months)
- Range of values (minimum, maximum, and spread) of Respiratory Rate in breaths per min measured by the gold standard and the Dozee(6 Months)
- Bland- Altman Level of Agreement between Dozee Heart Rate and Respiratory Rate with the Gold Standard(6 months)
- Detection rate (%) of the Dozee's Heart Rate and Respiratory Rate(6 months)
- Level of Agreement between Dozee Heart Rate and Respiratory Rate with the Gold Standard(6 months)