Trial document




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  DRKS00010103

Trial Description

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Title

Sleep Apnea in Subjects with Dementia (SADE)

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Trial Acronym

SADE

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Examination of the correlation between sleep apnea and dementia in 150 geriatric patients.

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Brief Summary in Scientific Language

Geriatric clinical patients will be investgated by polygraphy (device: Apnea-Link, Resmed) for one night.
Different parameters are recorded with standardized questionnaires and the correlation with the results of pulsoxymetry and polygraphy will be analyzed.
Aim of the study is to detect the prevalence of sleep apnea in patients with dementia and to determine which form of sleep apnea occurs in these patients.
Furthermore, we want to investigate whether the standard methods for sleep apnea diagnosis in demented patients are feasible.

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Organizational Data

  •   DRKS00010103
  •   2016/03/22
  •   [---]*
  •   yes
  •   Approved
  •   15-6467-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

  •   U1111-1180-9706 
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Health Condition or Problem studied

  •   F01 -  Vascular dementia
  •   F00 -  Dementia in Alzheimer disease
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Interventions/Observational Groups

  •   observational study without Intervention
    Geriatric clinical patients will be investgated by polygraphy (device: Apnea-Link, Resmed) for one night.
    Different parameters are recorded with standardized questionnaires and the correlation with the results of pulsoxymetry and polygraphy will be analyzed.
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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

association between severity of sleep apnea and cognitive function with polygraphy ( ApneaLink ) and neuropsychological tests

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Secondary Outcome

Association between sleep apnea and several parameters of a comprehensive geriatric assessment

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2016/04/20
  •   150
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Patients with dementia

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Exclusion Criteria

delirant patients
immobility
Barthel index < 30
terminal patients

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Addresses

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    • Neurologische Klinik, Universitätsklinikum Essen
    • Mr.  Prof. Dr. med.  Dirk  Herrmann 
    • Hufelandstr. 55
    • 45122  Essen
    • Germany
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    • Neurologische Klinik, Universitätsklinikum Essen
    • Mr.  Prof. Dr. med.  Dirk  Herrmann 
    • Hufelandstr. 55
    • 45122  Essen
    • Germany
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    • Klinik für Geriatrie und Zentrum für Altersmedizin, Knappschaftskrankenhaus Essen
    • Mr.  PD. Dr. med.  Helmut  Frohnhofen 
    • Am Deimelsberg 34a
    • 45276  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Geriatrie und Zentrum für Altersmedizin, Knappschaftskrankenhaus Essen
    • Mr.  PD Dr. med.  Helmut  Frohnhofen 
    • Am Deimelsberg 34a
    • 45276  Essen
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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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.