验证Dozee用于无接触监测心率、呼吸和活动的有效性
Dozee系统无接触监测心率、呼吸频率、活动及离床的临床验证
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
研究概览
详细说明
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 and to benchmark against the previous versions of the algorithms
研究类型
注册 (实际的)
联系人和位置
学习地点
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Texas
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Midland、Texas、美国、79707
- ERA Health Research
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
The study will be conducted on atleast 60 subjects in the age group above 18 years regardless of gender. The patients/volunteers be informed about the study and a written informed consent form will be obtained from them. Dozee will be placed under the mattress of the patient's bed and the data will be collected through the device whenever a patient is on the bed.
描述
Inclusion Criteria:
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.
Exclusion Criteria:
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.
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Single Arm Study (Cohort)
Group/Cohort Description: All participants will be on standard telemetry monitoring for Heart Rate and Respiration Rate using the gold standard (Electrocardiography and Capnography respectively). In addition, a contactless monitoring devices will be placed on the patient bed to measure data. This device is Dozee VS (Investigational Device). Data from all devices will be measured simultaneously. |
All participants will be on standard telemetry monitoring for Heart Rate, Respiration Rate and movements using the gold standard (Electrocardiography and Capnography respectively). |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Mean Absolute Error (MAE) of Dozee's Heart Rate a from the Gold Standard ECG
大体时间：6 months
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Heart Rate collected at 1 Min intervals from gold standard and Dozee. Mean Absolute Error (MAE) of the Dozee Heart Rate will be calculated. |
6 months
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Accuracy (%) of Dozee in identfying subject movement
大体时间：6 months
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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. |
6 months
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Accuracy(%) of of Dozee's bed-exits
大体时间：6 months
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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. |
6 months
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Mean Absolute Error (MAE) of Dozee's Respiratory Rate from the Gold Standard Capnography
大体时间：6 Months
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Respiratory Rate collected at 1 Min intervals from gold standard and Dozee. Mean Absolute Error (MAE) of the Dozee Respiratory Rate will be calculated. |
6 Months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Range of values (minimum, maximum, and spread) of Heart Rate in beats per min measured by the gold standard and the Dozee
大体时间：6 months
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The outcome will be assessed by comparing the range of values (minimum, maximum, and spread) of Heart Rate ( beats per minute) measured by the gold standard and the Dozee over the study period. |
6 months
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Range of values (minimum, maximum, and spread) of Respiratory Rate in breaths per min measured by the gold standard and the Dozee
大体时间：6 Months
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The outcome will be assessed by comparing the range of values (minimum, maximum, and spread) of Respiratory Rate ( breaths per minute) measured by the gold standard and the Dozee over the study period. |
6 Months
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Bland- Altman Level of Agreement between Dozee Heart Rate and Respiratory Rate with the Gold Standard
大体时间：6 months
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Level of Agreement between Dozee's HR and RR with reference device computed by Bland Altman. |
6 months
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Detection rate (%) of the Dozee's Heart Rate and Respiratory Rate
大体时间：6 months
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The time-stamps of Dozee's Heart Rate and Respiratory Rate and the gold standard Heart Rate and Respiratory Rate will be recorded. DR is the proportion of gold standard points for which the DS successfully provides a corresponding measured value, relative to the total number of gold standard points. |
6 months
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Level of Agreement between Dozee Heart Rate and Respiratory Rate with the Gold Standard
大体时间：6 months
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Level of Agreement between Dozee Heart Rate and Respiratory Rate with the Gold Standard by using Deming Regression with Pearson Co-efficient |
6 months
|
合作者和调查者
调查人员
- 首席研究员：Sapna Chilka, MD、ERA Health Research
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- DZ_VS_VAL
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Individual Participant Data (IPD) are protected under HIPPA Act of 1996.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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