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
Intervention / Treatment
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 and benchmark with the previous algorithms
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Lindsay Darthard, LVN LNFA
- Phone Number: 979-297-0425
- Email: lindsaydarthard@gcltc.com
Study Locations
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Texas
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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
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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?
Design Details
- Observational Models: COHORT
- Time Perspectives: PROSPECTIVE
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. |
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
Time Frame: 6 months
|
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
Time Frame: 6 months
|
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
Investigators
- Principal Investigator: Lindsay Darthard, LVN LNFA, Oak Village Healthcare
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- DZ_VS_VAL_ON
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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