Dozee Validation for Contactless Heart Rate and Respiration Monitoring in Clinical Settings

NCT07735403 | Recruiting FDA Device

• 1 other identifier: DZ_VS_VAL_ON
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

No specific Conditions

Outcome Measures

Primary Outcomes (2)

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

  Heart Rate collected at 1 Min intervals from gold standard and Dozee. Mean Absolute Error (MAE) of the Dozee Heart Rate will be calculated

  6 months

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

  Respiratory Rate collected at 1 Min intervals from gold standard and Dozee. Mean Absolute Error (MAE) of the Dozee Respiratory Rate will be calculated.

  6 months

Study Arms (1)

Single Arm Study (Cohort)

All participants will be on standard telemetry monitoring for Heart Rate and Respiration Rate using the gold standard (Electrocardiography and Capnography respectively). In addition, a contactless monitoring devices will be placed on the patient bed to measure data. This device is Dozee VS (Investigational Device). Data from all devices will be measured simultaneously.

Device: Telemetry monitoring

Interventions

Telemetry monitoring DEVICE

All participants will be on standard telemetry monitoring for Heart Rate, Respiration Rate and movements using the gold standard (Electrocardiography and Capnography respectively)

Single Arm Study (Cohort)

Eligibility Criteria

• Age: 22 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will be conducted on atleast 20 subjects in the age group of 22 years and above, regardless of gender. The patients/volunteers be informed about the study and a written informed consent form will be obtained from them. Dozee will be placed under the mattress of the patient's bed and the data will be collected through the device whenever a patient is on the bed

You may qualify if:

• Adults Male or female. (≥ 22 years of age)
• Provide written informed consent.
• Weight over 40kg/88.18lbs

You may not qualify if:

• 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

Sponsors & Collaborators

• Turtle Shell Technologies Pvt. Ltd.: lead

Study Sites (1)

Oak Village Healthcare

Lake Jackson, Texas, 77566, United States

RECRUITING

Study Officials

• Lindsay Darthard, LVN LNFA

  Oak Village Healthcare

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsay Darthard, LVN LNFA

CONTACT

979-297-0425; lindsaydarthard@gcltc.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 30, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)