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NCT07735403

Overview

NCT ID: NCT07735403
Lead Sponsor: Turtle Shell Technologies Pvt. Ltd.INDUSTRY
Official Title: Dozee System Validation for Contactless Heart Rate and Respiration Monitoring in Clinical Settings
Brief 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
Conditions: No Specific Medical Conditions or Disease States

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: 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

Central Contacts: Lindsay Darthard, LVN LNFAContact
lindsaydarthard@gcltc.com979-297-0425