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

Conditions

• No Specific Conditions
• No Specific Medical Conditions or Disease States

Eligibility Criteria

Sex

ALL

Age

18 Years - 100 Years

Healthy Volunteers

Accepted

Interventions

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

Study Details

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

Key Dates

Start date

Sep 16, 2025

Status verified

Oct 2025

Primary completion

Dec 20, 2025

Completion

Dec 31, 2025

Study Design

Enrollment

60 participants (estimated)

Arms

• Arm: 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.

Primary Outcome Measure

Mean Absolute Error (MAE) of Dozee's Heart Rate a from the Gold Standard ECG [ Time Frame: 6 months ]

Central Contacts

• Hinali Zhaveri
  559-554-2265
  [email protected]

Locations (1)

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