Status:
RECRUITING
Validating Dozee for Contactless Monitoring of Heart, Breathing, and Movemen
Lead Sponsor:
Turtle Shell Technologies Pvt. Ltd.
Collaborating Sponsors:
Eastside Research Associates
Conditions:
No Specific Medical Conditions or Disease States
No Specific Conditions
Eligibility:
All Genders
18-100 years
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...
Detailed Description
The Dozee VS system (K221555), developed by Turtle Shell Technologies, is a non-invasive, contactless device that continuously monitors heart rate (HR) and breathing rate (RR). A thin sensor sheet pla...
Eligibility Criteria
Inclusion
- Subjects will be included if they meet the following inclusion criteria:
- 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.
Exclusion
- Subjects will be excluded if they have any of the following inclusion 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.
Key Trial Info
Start Date :
September 16 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07223931
Start Date
September 16 2025
End Date
December 31 2025
Last Update
November 3 2025
Active Locations (1)
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1
ERA Health Research
Midland, Texas, United States, 79707