Trial document





This trial has been registered retrospectively.
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  DRKS00000772

Trial Description

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Title

Validation of the Essener Questionnaire of Age and Sleepiness in th Elderly using Pupillometry

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Daytime sleepiness in the elderly is assesed by a evaluation sheet - Essen questionnaire age and sleepiness, EQAS - and recorded simultaneously by the external, valid and objective method of pupillography. The pupillography serves as an objective measure of daytime sleepiness and is used for external validation of the EQAS.

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Brief Summary in Scientific Language

External validation of the construct of daytime sleepiness by determination using the external, objective and valid method of pupillogrphie and simultaneous determination of daytime sleepiness in the same subjects through an external assessment scales (EQAS Essen questionnaire of age and sleepiness). Review of both results using ROC analysis.
Since pupillometry is not feasible in most geriatric in-hospital patients, the inclusion of 100 patients is scheduled to obtain a valid pupillometry in at least 35 patients.

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Organizational Data

  •   DRKS00000772
  •   2013/05/28
  •   [---]*
  •   yes
  •   Approved
  •   2011440, Ethikkommission der Ärztekammer Nordrhein
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Secondary IDs

  •   U1111-1127-2232 
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Health Condition or Problem studied

  •   daytime sleepiness
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Interventions/Observational Groups

  •   External validation of the construct of daytime sleepiness by determination using the external, objective and valid method of pupillogrphie and simultaneous determination of daytime sleepiness in the same subjects through an external assessment scales (EQAS Essen questionnaire of age and sleepiness). Review of both results using ROC analysis.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Comparing two test methods for detecting sleepiness. The newly developed measurement methods (EFAS) is externally validated by means of a valid and objective method (pupillography).

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Secondary Outcome

N/A

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2012/01/16
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   70   Years
  •   no maximum age
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Additional Inclusion Criteria

geriatric in-hospital patients,
age over 70 years
no disease of the eye
written informed consent

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Exclusion Criteria

unstable clinical state
terminal clinical state
palliative patient
unwillingness to participate

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Kliniken Essen Mitte Zentrum für Altersmedizin
    • Mr.  Dr. med.  Helmut  Frohnhofen 
    • Am Deimelsberg 34a
    • 45276  Essen
    • Germany
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    • Kliniken Essen Mitte Zentrum für Altersmedizin
    • Mr.  Dr. med.  Helmut  Frohnhofen 
    • Am Deimelsberg 34a
    • 45276  Essen
    • Germany
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    end of 1:1-Block address contact scientific-contact
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    • Kliniken Essen Mitte Zentrum für Altersmedizin
    • Mr.  Dr. med.  Helmut  Frohnhofen 
    • Am Deimelsberg 34a
    • 45276  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Kliniken Essen Mitte Zentrum für Altersmedizin
    • Mr.  Dr. med.  Helmut  Frohnhofen 
    • Am Deimelsberg 34a
    • 45276  Essen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2012/11/30
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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.