Validación de Dozee para la Monitorización sin Contacto del Corazón, la Respiración y el Movimiento
Validación Clínica del Sistema Dozee para la Monitorización sin Contacto de la Frecuencia Cardíaca, la Frecuencia Respiratoria, el Movimiento y las Salidas de la Cama
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
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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 to benchmark against the previous versions of the algorithms
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Texas
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Midland, Texas, Estados Unidos, 79707
- ERA Health Research
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
Inclusion Criteria:
Subjects will be included if they meet the following inclusion criteria:
- Adults Male or female. (Above 18 years of age)
- Provide written informed consent.
- Weight between 40kg/88.18lbs and 120kg/264.55lbs
- Agree to not eat during the testing period
- 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:
- 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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. |
All participants will be on standard telemetry monitoring for Heart Rate, Respiration Rate and movements using the gold standard (Electrocardiography and Capnography respectively). |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mean Absolute Error (MAE) of Dozee's Heart Rate a from the Gold Standard ECG
Periodo de tiempo: 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
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Accuracy (%) of Dozee in identfying subject movement
Periodo de tiempo: 6 months
|
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
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Accuracy(%) of of Dozee's bed-exits
Periodo de tiempo: 6 months
|
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
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Mean Absolute Error (MAE) of Dozee's Respiratory Rate from the Gold Standard Capnography
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Range of values (minimum, maximum, and spread) of Heart Rate in beats per min measured by the gold standard and the Dozee
Periodo de tiempo: 6 months
|
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
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Range of values (minimum, maximum, and spread) of Respiratory Rate in breaths per min measured by the gold standard and the Dozee
Periodo de tiempo: 6 Months
|
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
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Bland- Altman Level of Agreement between Dozee Heart Rate and Respiratory Rate with the Gold Standard
Periodo de tiempo: 6 months
|
Level of Agreement between Dozee's HR and RR with reference device computed by Bland Altman. |
6 months
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Detection rate (%) of the Dozee's Heart Rate and Respiratory Rate
Periodo de tiempo: 6 months
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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
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Level of Agreement between Dozee Heart Rate and Respiratory Rate with the Gold Standard
Periodo de tiempo: 6 months
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Level of Agreement between Dozee Heart Rate and Respiratory Rate with the Gold Standard by using Deming Regression with Pearson Co-efficient |
6 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Sapna Chilka, MD, ERA Health Research
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- DZ_VS_VAL
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Individual Participant Data (IPD) are protected under HIPPA Act of 1996.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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