RecruitingNot Applicable

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

United States60 participantsStarted 2025-09-16

Plain-language 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

Who can participate

Age range18 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 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.

What they're measuring

Mean Absolute Error (MAE) of Dozee's Heart Rate a from the Gold Standard ECG

Timeframe: 6 months

Accuracy (%) of Dozee in identfying subject movement

Timeframe: 6 months

Accuracy(%) of of Dozee's bed-exits

Timeframe: 6 months

Mean Absolute Error (MAE) of Dozee's Respiratory Rate from the Gold Standard Capnography

Timeframe: 6 Months

Trial details

NCT IDNCT07223931

SponsorTurtle Shell Technologies Pvt. Ltd.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-12-20

Contact for this trial

Hinali Zhaveri

559-554-2265 hzaveri@erahealthresearch.com

View on ClinicalTrials.gov More No Specific Medical Conditions or Disease States trials

Plain-language summary

Who can participate

Age range18 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 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.

What they're measuring

Mean Absolute Error (MAE) of Dozee's Heart Rate a from the Gold Standard ECG

Timeframe: 6 months

Accuracy (%) of Dozee in identfying subject movement

Timeframe: 6 months

Accuracy(%) of of Dozee's bed-exits

Timeframe: 6 months

Mean Absolute Error (MAE) of Dozee's Respiratory Rate from the Gold Standard Capnography

Timeframe: 6 Months