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Completed
NCT07223931
Validating Dozee for Contactless Monitoring of Heart, Breathing, and Movemen
Conditions: No Specific Medical Conditions or Disease States, No Specific Conditions
Sex: All
Ages: 18 Years – 100 Years
Healthy volunteers: Yes
Enrollment: 91
Sponsor: Turtle Shell Technologies Pvt. Ltd.
Location: ERA Health Research Midland Texas
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 Criteria
Inclusion Criteria:
Subjects will be included if they meet the following inclusion criteria:
1. Adults Male or female. (Above 18 years of age)
2. Provide written informed consent.
3. Weight between 40kg/88.18lbs and 120kg/264.55lbs
4. Agree to not eat during the testing period
5. Able to move and exit the bed independently and safely.
Exclusion Criteria:
Subjects will be excluded if they have any of the following inclusion criteria:
1. Are connected to a device that may interfere with the device monitoring in this study.
2. Are receiving any bedside care which may be incompatible with the study procedures.
3. A likely need to receive or undergo a procedure during the testing period.
4. Cannot accept a nasal cannula, or have an ECG leads placed on the chest.
5. Have a significant medical condition in the judgement of the investigator, which may compromise the study testing procedures.
Source: ClinicalTrials.gov (NCT07223931). StuddyBuddy aggregates publicly available trial information.