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

Официальное название

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

Обзор

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

Подробное описание

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

Вмешательства

• Устройство 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)

Первичные конечные точки

• Mean Absolute Error (MAE) of Dozee's Heart Rate a from the Gold Standard ECG [Срок оценки: 6 months]
• Mean Absolute Error (MAE) of Dozee's Respiratory Rate from the Gold Standard Capnography [Срок оценки: 6 months]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Oak Village Healthcare — Lake Jackson

Идентификаторы

NCT: NCT07735403 · DZ_VS_VAL_ON

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗