RecruitingNCT07223931

Validating Dozee for Contactless Monitoring of Heart, Breathing, and Movemen

Clinical Validation of the Dozee System for Contactless Monitoring of Heart Rate, Respiration Rate, Motion, and Bed-Exits


Sponsor

Turtle Shell Technologies Pvt. Ltd.

Enrollment

60 participants

Start Date

Sep 16, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria10

  • 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.
  • 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.

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Interventions

DEVICEDevice: 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).


Locations(1)

ERA Health Research

Midland, Texas, United States

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NCT07223931