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

NCT07223931 | Recruiting FDA Device

• 1 other identifier: DZ_VS_VAL
• Study Type: observational
• Target: 60
• 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; No Specific Conditions

Outcome Measures

Primary Outcomes (4)

• 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

• Accuracy (%) of Dozee in identfying subject movement

  Time stamps of subject movement during the study will be recorded manullay. Time stamps of Dozee's movement will be recorded. Accuracy of the Dozee device in detecting movement compared to manual observation will be computed in terms of percentage.

  6 months

• Accuracy(%) of of Dozee's bed-exits

  Time stamps of bed-exits will be recorded manually during the study will be recorded. Time stamps of Dozee's bed-exit will be computed. Accuracy of the Dozee device in detecting bed-exit compared to manual observation as gold standard will be computed in terms of percentage.

  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

Secondary Outcomes (5)

• Range of values (minimum, maximum, and spread) of Heart Rate in beats per min measured by the gold standard and the Dozee

  6 months

• Range of values (minimum, maximum, and spread) of Respiratory Rate in breaths per min measured by the gold standard and the Dozee

  6 Months

• Bland- Altman Level of Agreement between Dozee Heart Rate and Respiratory Rate with the Gold Standard

  6 months

• Detection rate (%) of the Dozee's Heart Rate and Respiratory Rate

  6 months

• Level of Agreement between Dozee Heart Rate and Respiratory Rate with the Gold Standard

  6 months

Study Arms (1)

Single Arm Study (Cohort)

Group/Cohort Description: 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: Device: Telemetry monitoring

Interventions

Device: 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: 18 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 60 subjects in the age group above 18 years 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. (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.

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.

Sponsors & Collaborators

• Turtle Shell Technologies Pvt. Ltd.: lead
• Eastside Research Associates: collaborator

Study Sites (1)

ERA Health Research

Midland, Texas, 79707, United States

RECRUITING

Study Officials

• Sapna Chilka, MD

  ERA Health Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hinali Zhaveri

CONTACT

559-554-2265; hzaveri@erahealthresearch.com

Study Design

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

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: November 3, 2025
• Study Start: September 16, 2025
• Primary Completion: December 20, 2025
• Study Completion: December 31, 2025
• Last Updated: November 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)