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

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

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

Study Overview

• Status: Recruiting
• Conditions: No Specific Medical Conditions or Disease States
• Intervention / Treatment: Device: Telemetry monitoring

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 placed under the mattress detects tiny body vibrations from the heart and lungs, which are processed by smart algorithms and displayed on a secure online dashboard for real-time monitoring.Unlike traditional methods such as ECGs, nasal tubes, or thermistors-which are invasive, require skilled placement, and are uncomfortable for long-term use-Dozee is simple, comfortable, and doesn't rely on patient compliance like wearables do. The system can also connect to add-on devices, including a blood pressure cuff, pulse oximeter, and thermometer, giving a full picture of a patient's vital signs and helping spot early signs of deterioration. Hardware upgrades now include dual-sensor sheets that improve accuracy across different mattresses and patient types. The new HR algorithm uses AI/ML for better accuracy, while the improved RR algorithm performs more reliably even with movement or weak signals.Study Goal: This study aims to validate the updated algorithms (Gen 2) for HR and RR across the three sensor sheet types (DS, S1, and S1-I) to ensure they meet clinical accuracy standards

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Lindsay Darthard, LVN LNFA; Phone Number: 979-297-0425; Email: lindsaydarthard@gcltc.com

Study Locations

• United States
  • Texas
    • Lake Jackson, Texas, United States, 77566
      • Recruiting
      • Oak Village Healthcare
      • Contact: Lindsay Darhtard, LVN LNFA; Phone Number: 979-297-0425; Email: lindsaydarthard@gcltc.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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

Description

Inclusion Criteria:

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

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.
• Prisoners

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; All participants will be on standard telemetry monitoring for Heart Rate, Respiration Rate and movements using the gold standard (Electrocardiography and Capnography respectively)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Turtle Shell Technologies Pvt. Ltd.
• Investigators: Principal Investigator: Lindsay Darthard, LVN LNFA, Oak Village Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 24, 2026
• First Submitted That Met QC Criteria: July 29, 2026
• First Posted (Actual): July 30, 2026

Study Record Updates

• Last Update Posted (Actual): July 30, 2026
• Last Update Submitted That Met QC Criteria: July 29, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: No specific Conditions
• Other Study ID Numbers: DZ_VS_VAL_ON

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual Participant Data (IPD) are protected under HIPPA Act of 1996

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No