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Evaluation of Performance, Usability, and Reliability of a Novel Device for Continuous Collection of Physiological Data

22 de enero de 2019 actualizado por: MC10 Inc.

A Study to Evaluate the Performance, Usability, and Reliability of a Novel Device for Continuous Collection of Physiological Data in Healthcare and Remote Settings

Study objective: The primary objective of the clinical investigation is to evaluate the accuracy of BioStamp nPoint system algorithm measurements.

Study design: A single-site, non-significant risk, open-label, prospective non-randomized clinical investigation designed to validate the accuracy of the various physiological parameters that the Wearable Sensor Patches acquire and the system processes.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

30

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45212
        • CTI Clinical Research Center

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 99 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Male or female volunteers, at least 18 years of age at the time of screening visit;
  2. Fluent in English;
  3. The subject is willing to comply with the protocol specified evaluations;
  4. Subject is willing and cognitively able to sign informed consent

Exclusion Criteria:

  1. Pregnancy;
  2. Positive urine drug screen
  3. History of active (clinically significant) skin disorders;
  4. History of allergic response to silicones or adhesives;
  5. Subjects with electronic implants of any kind (e.g. pacemaker)
  6. History of sleep disorders or self-reported insomnia or other sleep conditions;
  7. Broken, damaged or irritated skin or rashes near the sensor application sites;
  8. Subjects that are MC10 employees or shareholders, or a spouse or child of an MC10 employee or shareholder;
  9. Subjects who are physically or cognitively unable to normally perform activities of daily living, assessed at the discretion of the investigator.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Otro
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Otro: Single Arm

This single arm consists of all subjects which will interact with the device under investigation as well as comparator devices.

This includes the Physiological signal monitor intervention, Heart rate and heart rate variability comparison device intervention, Respiration rate comparison device intervention, and Activity classification intervention.
Dispositivo: Physiological signal monitor
Wireless remote monitoring system intended for use by researchers and healthcare professionals for continuous collection of physiological data in home and healthcare settings.
Dispositivo: Heart rate and heart rate variability comparison device
FDA cleared reference device that monitors heart rate and heart rate variability in subjects
Dispositivo: Respiration rate comparison device
FDA cleared reference device that monitors respiration rate in subjects
Otro: Activity classification
Visual annotation of subject posture and other activities used for reference

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Accuracy of Heart Rate Measured in Beats Per Minute Compared to Reference Device
Periodo de tiempo: 2 days after informed consent
Heart rate as measured by the subject device in beats per minute will be compared to the reference device. The Mean Absolute Error (MAE) between measurements from each device is presented.
2 days after informed consent
Accuracy of Heart Rate Variability Measured by Root Mean Square of Successive Differences (HRV RMSSD) Compared to the Reference Device
Periodo de tiempo: 2 days after informed consent
Heart Rate Variability RMSSD is measured by the subject device determined by root mean square of successive differences in neighboring RR intervals and will be compared to the reference device. The Mean Absolute Error (MAE) between measurements from each device is presented.
2 days after informed consent
Accuracy of Heart Rate Variability Measured by Low Frequency Content to High Frequency Content Ratio (HRV Ratio) Compared to the Reference Device
Periodo de tiempo: 2 days after informed consent
HRV Ratio as measured by the subject device determined by low frequency content to high frequency content ratio (HRV Ratio) in beats per minute will be compared to the reference device. The Mean Absolute Error (MAE) between measurements from each device is presented.
2 days after informed consent
Accuracy of Respiration Rate Measured in Breaths Per Minute Compared to the Reference Device
Periodo de tiempo: 2 days after informed consent
Respiration rate as measured by the subject device in breaths per minute will be compared to the reference device. The Mean Absolute Error (MAE) between measurements from each device is presented.
2 days after informed consent
Accuracy of Activity Classification as Compared to Visual Annotation
Periodo de tiempo: 2 days after informed consent
The device under test will classify a subjects activity into sleeping, standing, sitting, lying, walking and other activities as the subject performs various predefined activities, which are annotated by an observer. The device's Activity Classification will be compared to the observer's annotation. The percentage of correct classifications by the device against indicated visual observation is presented. The percent correct is not a per subject average, but is the percentage of all activity classifications which were correct when compared to ground truth observation.
2 days after informed consent
Accuracy of Step Count Compared to an Observer's Manual Count
Periodo de tiempo: 2 days after informed consent
The number of steps reported by the device under test during a 6 minute walk test will be compared to an observer's manual count of the number of steps taken.
2 days after informed consent
Accuracy of Sleep Onset Time (Hours, Minutes, and Seconds), Sleep Wake Time (Hours, Minutes, and Seconds) as Compared to an Observer's Visual Annotation
Periodo de tiempo: 2 days after informed consent
Sleep onset and wake times as reported by the device under test will be compared to an observer's visual annotation of the sleep onset and wake times. The Mean Absolute Error (MAE) between times as indicated by the device and observed times is presented.
2 days after informed consent
Accuracy of Posture Classification as Compared to Visual Annotation
Periodo de tiempo: 2 days after informed consent
The device under test will classify a subjects activity into sleep posture, standing posture, and sitting posture as the subject performs various predefined activities, which are annotated by an observer. The device's Posture Classification will be compared to the observer's annotation. The percentage of correct classifications by the device against indicated visual observation is presented. The percent correct is not a per subject average, but is the percentage of all posture classifications which were correct when compared to ground truth observation.
2 days after informed consent
Number of Sensors That Remained Sufficiently Adhered to Subjects for 24 Hours as Assessed by a 5 Point Scale
Periodo de tiempo: 2 days after informed consent
The level of sensor adhesion will be assessed by a 5 point scale (0- sensor is greater than or equal to 90% of sensor adhered, 4-sensor completely detached from subject). Sensors receiving scores of 0 and 1 will be determined to have acceptable adhesion, while scores of 2, 3, and 4 will be considered unacceptable adhesion. The percentage of sensors which had acceptable adhesion at sensor removal is presented.
2 days after informed consent

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

MC10 Inc.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

31 de julio de 2017

Finalización primaria (Actual)

25 de agosto de 2017

Finalización del estudio (Actual)

30 de agosto de 2017

Fechas de registro del estudio

Enviado por primera vez

16 de agosto de 2017

Primero enviado que cumplió con los criterios de control de calidad

17 de agosto de 2017

Publicado por primera vez (Actual)

22 de agosto de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de enero de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

22 de enero de 2019

Última verificación

1 de enero de 2019

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • MC10-PTL-103

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Sí

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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