Trial document





This trial has been registered retrospectively.
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  DRKS00008902

Trial Description

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Title

Activity of stress-related systems, metabolic consequences and genetics of restless legs syndrome, periodic limb movements, parasomnias, narcolepsy and healthy controls

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Trial Acronym

ASS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

We use simple, but standardized methods to monitor the activity of stress-related hormones in patients of the sleep laboratory of the central institute of mental health. Also, we collect blood for the investigation of metabolic disturbances and genetic analyses. Thereby, a large number of samples of patients with various sleep disorders is availabe to study the relationship between sleep disorders and consecutive medical disorders.

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Brief Summary in Scientific Language

We generate a biobank with samples of patients with various sleep disorders and healthy controls. We intend to study the relationship between stress hormones (e.g. cortisol in urine) and metabolic as well as endocrine disorders. Also, we collect DNA for future genetic analyses.

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Organizational Data

  •   DRKS00008902
  •   2015/07/13
  •   [---]*
  •   yes
  •   Approved
  •   2011-315N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   F51.0 -  Nonorganic insomnia
  •   G25.8 -  Other specified extrapyramidal and movement disorders
  •   G47.4 -  Narcolepsy and cataplexy
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Interventions/Observational Groups

  •   primary insomnia (analysis of existing blood samples)
  •   Restless legs syndrome (analysis of existing blood samples)
  •   narcolepsy + other parasomnias (analysis of existing blood samples)
  •   healthy controls (analysis of existing blood samples)
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Characteristics

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

Endpoints are metabolic features (cholesterol, fasting glucose etc.) and endocrinological parameters (adipokines, BDNF and others) in blood samples that are collected in the framework of a clinical routine blood withdrawal. Relevant endpoints are laboratory features of the metabolic syndrome (triglycerides, LDL-, HDL- and total cholesterol, fasting glucose) as well as endocrinological variables like adipokines (proteins secreted by fat tissue like leptin, adiponektin) and growth factors, like insulin-like growth factor-1 (IGF-1) and brain-derived neurotrophic factor (BDNF). Cortisol in night urine is an independent variable, which - as well as polysomnography and clinical diagnoses - is relevant for the determination of study groups.

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2011/08/25
  •   1000
  •   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 sleep disorder (see above) that is confirmed by polysomnography

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Exclusion Criteria

inability to consent

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Zentralinstitut für Seelische Gesundheit
    • Mr.  Prof. (apl) Dr. med.  Michael  Deuschle 
    • J5
    • 68159  Mannheim
    • Germany
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    • Zentralinstitut für Seelische Gesundheit
    • Mr.  Prof. (apl) Dr. med.  Michael  Deuschle 
    • J5
    • 68159  Mannheim
    • Germany
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    • Zentralinstitut für Seelische Gesundheit
    • Mr.  Prof. (apl) Dr. med.  Michael  Deuschle 
    • J5
    • 68159  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Zentralinstitut für Seelische Gesundheit
    • J5
    • 68159   Mannheim
    • 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.