Dozee Validation for Contactless Heart Rate and Respiration Monitoring in Clinical Settings
Purpose
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
Condition
- No Specific Medical Conditions or Disease States
Eligibility
- Eligible Ages
- Between 22 Years and 100 Years
- Eligible Sex
- All
- Accepts 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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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. |
|
Recruiting Locations
Lake Jackson, Texas 77566
More Details
- Status
- Recruiting
- Sponsor
- Turtle Shell Technologies Pvt. Ltd.
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