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

RECRUITINGSponsored by Turtle Shell Technologies Pvt. Ltd.
Actively Recruiting
SponsorTurtle Shell Technologies Pvt. Ltd.
Started2025-09-16
Est. completion2025-12-20
Eligibility
Age18 Years – 100 Years
Healthy vol.Accepted
Locations1 site

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

Age: 18 Years – 100 YearsHealthy volunteers accepted
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.

Conditions3

Heart DiseaseNo Specific ConditionsNo Specific Medical Conditions or Disease States

Locations1 site

ERA Health Research
Midland, Texas, 79707

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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