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

Clinical Validation of the Dozee System for Contactless Monitoring of Heart Rate, Respiration Rate, Motion, and Bed-Exits

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; No Specific Conditions
• Intervention / Treatment: Device: 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): 60

Contacts and Locations

• Study Contact: Name: Hinali Zhaveri; Phone Number: 559-554-2265; Email: hzaveri@erahealthresearch.com

Study Locations

• United States
  • Texas
    • Midland, Texas, United States, 79707
      • Recruiting
      • Era Health Research

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 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of values (minimum, maximum, and spread) of Heart Rate in beats per min measured by the gold standard and the Dozee	The outcome will be assessed by comparing the range of values (minimum, maximum, and spread) of Heart Rate ( beats per minute) measured by the gold standard and the Dozee over the study period.	6 months
Range of values (minimum, maximum, and spread) of Respiratory Rate in breaths per min measured by the gold standard and the Dozee	The outcome will be assessed by comparing the range of values (minimum, maximum, and spread) of Respiratory Rate ( breaths per minute) measured by the gold standard and the Dozee over the study period.	6 Months
Bland- Altman Level of Agreement between Dozee Heart Rate and Respiratory Rate with the Gold Standard	Level of Agreement between Dozee's HR and RR with reference device computed by Bland Altman.	6 months
Detection rate (%) of the Dozee's Heart Rate and Respiratory Rate	The time-stamps of Dozee's Heart Rate and Respiratory Rate and the gold standard Heart Rate and Respiratory Rate will be recorded. DR is the proportion of gold standard points for which the DS successfully provides a corresponding measured value, relative to the total number of gold standard points.	6 months
Level of Agreement between Dozee Heart Rate and Respiratory Rate with the Gold Standard	Level of Agreement between Dozee Heart Rate and Respiratory Rate with the Gold Standard by using Deming Regression with Pearson Co-efficient	6 months

Collaborators and Investigators

• Sponsor: Turtle Shell Technologies Pvt. Ltd.
• Collaborators: Eastside Research Associates
• Investigators: Principal Investigator: Sapna Chilka, MD, Era Health Research

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2025
• Primary Completion (Estimated): December 20, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 23, 2025
• First Submitted That Met QC Criteria: October 30, 2025
• First Posted (Estimated): November 3, 2025

Study Record Updates

• Last Update Posted (Estimated): November 3, 2025
• Last Update Submitted That Met QC Criteria: October 30, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: DZ_VS_VAL

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