Trial document




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  DRKS00012458

Trial Description

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Title

Analysis of the circadian rhythms of xerostomia, drooling and dysphagie among Parkinson's disease patients

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Trial Acronym

Salivation in Parkinson's disease

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URL of the Trial

[---]*

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Brief Summary in Lay Language

With a questionnaire, we try to investigate if the symptoms drooling, dysphagie and xerostomia appear in characteristic times and if they depend on each other

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Brief Summary in Scientific Language

In recent investigations, we could show that Parkinson's disease patients Report to suffer from Xerostomia, drooling and dysphagia. With this explorative study we try to show characteristica in the circadian day and try to show if there are associations in between These symptoms or with certain daily activities

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Organizational Data

  •   DRKS00012458
  •   2017/06/16
  •   [---]*
  •   yes
  •   Approved
  •   17-194, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   R68.2 -  Dry mouth, unspecified
  •   G20 -  Parkinson disease
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Interventions/Observational Groups

  •   75 Parkinson's disease patients complete a questionnaire and send it back. As is a diary, participants mark once each our if they suffer from dry mouth, dysphagia or hypersalivation. Additionnally, they report if they did any daily acticities such as eating or medication intake.
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Characteristics

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

Correlation between the symptoms dry mouth, dysphagia and hypersalivation investigated by a diary-like questionnaire.

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Secondary Outcome

Are their influencing factors that are associated with the occurence of one of these symptoms?

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/07/15
  •   75
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Parkinson's disease

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Exclusion Criteria

none

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Addresses

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    • Uniklinik Köln Abteilung für Zahnerhaltung und Parodontologie
    • Ms.  Dr. Dr.  Greta  Barbe 
    • Kerpener Str. 32
    • 50931  Köln
    • Germany
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    • Uniklinik Köln, Abteilung für Zahnerhaltung und Parodontologie
    • Mr.  Univ.-Prof.  Michael  Noack 
    • Rurstr. 33
    • 50935  Köln
    • Germany
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    • Uniklinik Köln Abteilung für Zahnerhaltung und Parodontologie
    • Ms.  Dr. Dr.  Greta  Barbe 
    • Kerpener Str. 32
    • 50931  Köln
    • Germany
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    • Uniklinik Köln Abteilung für Zahnerhaltung und Parodontologie
    • Ms.  Dr. Dr.  Greta  Barbe 
    • Kerpener Str. 32
    • 50931  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Uniklinik Köln, Abteilung für Zahnerhaltung und Parodontologie
    • Mr.  Univ.-Prof.  Michael  Noack 
    • Rurstr. 33
    • 50935  Köln
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/12/31
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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.