Trial document




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  DRKS00009767

Trial Description

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Title

Relevance of sleepiness questionnaires in patients with chronic pruritus

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Trial Acronym

SST-Pr-24-2015

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Many patients suffer from chronic itch (medical term: pruritus). Some find themselves especially itchy at nighttime, causing them to lose sleep. In this study, sleep evaluation questionnaires that have already successfully been implemented into various patient groups will be further utilized to document the specific sleep disturbances of those with chronic pruritus.
Patients are asked to complete the questionnaires twice. It is intended for patients to work on the questionnaires during their outpatient or residential visit for pruritus, during which a therapy will be adjusted to their needs, if necessary. After 4 weeks, patients are asked to complete the questionnaires once more in order to compare their sleeping habits before and after the adjustments to their therapy. Pruritus intensity is documented parallel to sleeping habits. Other questions include general inquiries regarding sleep disturbances and sleep disturbances due to pruritus or medications. These are important factors because, besides pruritus, there are many other causes for sleep disturbances that need to be taken into consideration during the evaluation.
The selection of sleep evaluation questionnaires that will be tested over time are, on one hand, based on interviews with patients with chronic pruritus, and on the other, are a mixture of the most common questions used in known sleep questionnaires. We also chose to test the Pittsburgh Sleep Quality Index, a sleep evaluation instrument consisting of 19 self-assessment questions and 5 third-party assessment questions that is already used in evaluating numerous diseases.

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Brief Summary in Scientific Language

Current methods of detecting possible sleep disturbances caused by chronic pruritus during routine examinations remain insufficient and disorganized. This study aims to determine whether the use of a sleep questionnaire can be beneficial in remedying this situation, and if so, to also ascertain which are best suited for this task.
Patients with chronic pruritus complete the Pittsburgh Sleep Quality Index, a self-designed sleep evaluation questionnaire and questions pertaining to pruritus intensity (e.g. the visual analogue scale) at intervals of 4 weeks, respectively.

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Organizational Data

  •   DRKS00009767
  •   2015/12/15
  •   [---]*
  •   yes
  •   Approved
  •   2015-430-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

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

  •   L29.9 -  Pruritus, unspecified
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Interventions/Observational Groups

  •   Patients with chronic pruritus fill in the Pittsburgh Sleep Quality Index, another sleepiness questionnaire, as well as questions on pruritus intensity (eg visual analogue scale) twice in four weeks.
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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

Detecting the relevance of the use of sleep questionnaires in patients with pruritus

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Secondary Outcome

Measureing the quality of sleep and the intensity of pruritus in the course

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/11/26
  •   90
  •   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

Patients with Pruritus

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Exclusion Criteria

under 18 years old

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikm MünsterKompetenzzentrum Chronischer Pruritus und Klinik für Hautkrankheiten
    • Ms.  Prof. Dr. Dr.   Sonja  Ständer 
    • Von-Esmarch-Str. 58
    • 48149  Münster
    • Germany
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    • Klinik für Hautkrankheiten und Kompentenzzentrum Chronischer Pruritus
    • Ms.  Prof.  Sonja  Ständer 
    • Von-Esmarch-Straße 58
    • 48149  Münster
    • Germany
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    • Klinik für Hautkrankheiten und Kompetenzzentrum Chronischer Pruritus
    • Ms.  Emil Rose  Burnett 
    • Von-Esmarch-Straße 58
    • 48149  Münster
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Hautkrankheiten und Kompentenzzentrum Chronischer Pruritus
    • Ms.  Prof.  Sonja  Ständer 
    • Von-Esmarch-Straße 58
    • 48149  Münster
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/12/15
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Trial Publications, Results and other Documents

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