No Specific Medical Conditions or Disease States
Conditions
Keywords
No specific Conditions
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
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
Interventions
DEVICETelemetry monitoring
All participants will be on standard telemetry monitoring for Heart Rate, Respiration Rate and movements using the gold standard (Electrocardiography and Capnography respectively)
Sponsors
Turtle Shell Technologies Pvt. Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to 100 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Absolute Error (MAE) of Dozee's Heart Rate a from the Gold Standard ECG | 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 |
| Mean Absolute Error (MAE) of Dozee's Respiratory Rate from the Gold Standard Capnography | 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. |
Countries
United States
Contacts
CONTACTLindsay Darthard, LVN LNFA
PRINCIPAL_INVESTIGATORLindsay Darthard, LVN LNFA
Oak Village Healthcare
Outcome results
None listed