Pilot Evaluation of an Continuous Contactless Vitals Parameter Monitoring System Dozee VS

Summary

The Dozee VS device developed by Turtle Shell Technologies Pvt. Ltd., is a contactless continuous vital parameters monitoring system. It is designed for continuous and contactless measurement of Heart Rate (HR) and Respiratory Rate (RR). The device uses the concept of ballistocardiography and deploys piezoelectric sensors to capture the micro-vibrations originating from cardiac contractions, upper respiratory tract activity and body movements. This data is then analyzed by a proprietary algorithm and the values of the vital parameters - Heart Rate (HR) and Respiratory Rate (RR) are generated. The captured vital parameters can be accessed remotely via a dashboard which can be accessed on any web browser and a smartphone application. The sensor sheet is placed below the mattress and captures data while the user is resting or sleeping and does not require a sensor to be fixed to the body. It consists of the following sub - units: Contactless sensor sheet, Dozee Pod with power cord, 5 Volt Universal Serial Bus (USB) Power Adapter, Health data compute server and Web Dashboard/Mobile App. This provides a more comfortable solution for long-term continuous patient monitoring. Continuous monitoring of people's vital signs, in particular Heart Rate (HR) and Respiratory Rate (RR), may provide a mechanism to alert doctors or nurses of clinical deterioration. Monitoring people's vital signs outside an ICU often relies on nursing staff conducting checks at set intervals. The device can reduce the workload for nursing staff in non-ICU wards.

Conditions

• No Specific Medical Conditions or Disease States

Interventions

DEVICE

Telemetry monitoring

All participants will be on standard telemetry monitoring for Heart Rate, Respiration Rate and movements using the gold standard (Electrocardiography and Capnography respectively).

DEVICE

Continuous monitoring through Earlysense

EarlySense (USFDA approved ballistocardiography device) will be placed under the patients mattress to measure Heart Rate, Respiratory Rate and movements

DEVICE

Continuous monitoring through Dozee VS

Dozee VS will be placed under the patients mattress to measure Heart Rate, Respiratory Rate and movements

Sponsors & Collaborators

• Eastside Research Associates

  collaborator UNKNOWN

• HealthMinds

  collaborator UNKNOWN

• Turtle Shell Technologies Pvt. Ltd.

  lead INDUSTRY

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-04-28

Primary Completion

2022-06-03

Completion

2022-06-10

FDA Device

Yes

Countries

• United States

Study Locations