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Dozee Validation for Contactless Heart Rate and Respiration Monitoring in Clinical Settings

2026年7月29日 更新者:Turtle Shell Technologies Pvt. Ltd.

Dozee System Validation for Contactless Heart Rate and Respiration Monitoring in Clinical Settings

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

研究类型

观察性的

注册 (估计的)

20

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Texas
      • Lake Jackson、Texas、美国、77566
        • 招聘中
        • Oak Village Healthcare
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

取样方法

概率样本

研究人群

The study will be conducted on atleast 20 subjects in the age group of 22 years and above, 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:

  • Adults Male or female. (≥ 22 years of age)
  • Provide written informed consent.
  • Weight over 40kg/88.18lbs

Exclusion 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.
  • Prisoners

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Single Arm Study (Cohort)
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
Mean Absolute Error (MAE) of Dozee's Heart Rate a from the Gold Standard ECG
大体时间: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
6 months
Mean Absolute Error (MAE) of Dozee's Respiratory Rate from the Gold Standard Capnography
大体时间: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.
6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Lindsay Darthard, LVN LNFA、Oak Village Healthcare

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月15日

初级完成 (估计的)

2026年12月15日

研究完成 (估计的)

2026年12月31日

研究注册日期

首次提交

2026年7月24日

首先提交符合 QC 标准的

2026年7月29日

首次发布 (实际的)

2026年7月30日

研究记录更新

最后更新发布 (实际的)

2026年7月30日

上次提交的符合 QC 标准的更新

2026年7月29日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • DZ_VS_VAL_ON

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

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

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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