Trial document




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  DRKS00023917

Trial Description

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Title

Digital Monitoring of the course of disease in COVID-19 via wearable in-ear sensors

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Trial Acronym

DiAssCo-ICU

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Project branch I will evaluate the diagnostic accuracy of the in-ear sensor Cosinuss(r) Two compared to gold standard monitoring on ICU.
Project branch II will apply the sensor to ventilated and non-ventilated patients after infection with SARS-CoV-2 in order to record longitudinally vital signs, body temperature, and head movements. These parameters will be conjuncted to disease related and socio-economic outcomes of the patients.
The main focus lies on the identification of predictive variables for the disease course of COVID-19. That's why the entire course of disease will be monitored by the sensor until recovery.

Project branch III will use the the sensor in order to monitor SARS-CoV-2 symptoms in employers of health care providers.

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Brief Summary in Scientific Language

Predictive modeling of the disease course based on vital signs and physical movements/ activity. Output parameters comprise indicative variables of disease-related health-care procedures, and socio-economic burden of disease

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

sharing of data sets, modeling algorithms

Data can be applied by direct application form with an existing cooperation contract within 5 years after study termination

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Organizational Data

  •   DRKS00023917
  •   2020/12/17
  •   [---]*
  •   yes
  •   Approved
  •   20-0455, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   COVID-19
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Interventions/Observational Groups

  •   validation of data accuracy of the sensor compared to the gold standard of continuous monitoring

    Data acquisition of 4 days during ICU treatment
  •   longitudinal acquisition of vital sign and movements, predictive modeling

    inclusion <24h after positive PCR

    data acquisition is continuous (not discreet) for the individual entire course of disease (not specified prior to inclusion)
    daily virtual visits for assessing data accuracy of the sensor data
  •   early identification of symptoms, employees of health care providers

    inclusion <24h after SARS-CoV-2 contact

    data acquisition is continuous (not discreet) for the individual entire course of disease (not specified prior to inclusion)
    daily virtual visits for assessing data accuracy of the sensor data
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Prognosis
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

course of disease

complications (rate, details)

admission to ICU
stay on ICU

hospital stay (d)

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Secondary Outcome

fractal dimensions, AI-based modeling

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2021/01/04
  •   126
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   110   Years
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Additional Inclusion Criteria

PCR positive COVID-19

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Exclusion Criteria

active otitis externa

former infections with SARS-CoV-2

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinikum der Universität München, Campus Großhadern
    • Mr.  PD Dr. med.  Roman  Schniepp 
    • Marchioninistraße 15
    • 81377  München
    • Germany
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    • Klinikum der Universität München, Campus Großhadern
    • Mr.  PD Dr. med.  Roman  Schniepp 
    • Marchioninistraße 15
    • 81377  München
    • Germany
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    • Klinikum der Universität München, Campus Großhadern
    • Mr.  PD Dr  Roman  Schniepp 
    • Marchioninistraße 15
    • 81377  München
    • Germany
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Sources of Monetary or Material Support

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    • Klinikum der Universität München, Campus Großhadern
    • Marchioninistraße 15
    • 81377  München
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.