Trial document




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  DRKS00000816

Trial Description

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Title

Sleep quality in patients with cerebral lymphoma

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Trial Acronym

Lymphoma-Sleep

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Cerebral lymphoma is an acute malign disease of the brain with good treatment options. The symptoms appear acute and are comparable to patients with stroke. In stroke-patients cerebral breathing disorders during sleep have been discovered. This study therefore aims at investigating the occurence of sleep disorders in patients with newly diagnosed cerebral lymphoma with non-invasive polysomnographia. A control polysomnographia is planned after two sessions of chemotherapy.

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Brief Summary in Scientific Language

In patients with lymphoma, obstructive apneas due to obstrctions of the upper pharynx have been described previously as a first sign of disease. Central apneas are a complex breathing disorder at night in which no breathing effort occurs at all. These kind of sleeping disorders severely affect sleep qualitys and health related quality of life. Additionally it has been shown previously that central apneas appear in patients with current stroke.
Cerebral lymphoma is a non-hodgkin lymphoma. All parts of the central nervous system can be affected. Patients with cerebral lymphoma appear with comparable symptoms as patients with stroke.
The aim of the current study is the assessment of central apneas in patients with newly diagnosed cerebral lymphoma. Additionally, sleep quality will be assessed a second time after treatment with two cycles of chemotherapy.

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Organizational Data

  •   DRKS00000816
  •   2011/04/18
  •   [---]*
  •   yes
  •   Approved
  •   145/11, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1120-8156 
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Health Condition or Problem studied

  •   C85.1 -  B-cell lymphoma, unspecified
  •   G47.3 -  Sleep apnoea
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Interventions/Observational Groups

  •   Polysomnographia, control polysomnographia after two sessions of chemotherapy
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Characteristics

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

Occurence of central apneas (>5/hour) as assessed by polysomnographia at primary diagnosis and after two sessions of chemotherapy

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Secondary Outcome

Sleep quality as assessed by determination of sleep stages during polysomnographia at primary diagnosis and after two sessions of chemotherapy

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2011/04/17
  •   30
  •   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

newly diagnosed, untreated cerebral lymphoma

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Exclusion Criteria

known complex breathing disorder
Hypercapnia
COPD GOLD III/IV
Cheyne-Stokes Breathing dirsorder
heart insufficiency
known central sleep apnoea
stroke

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Uniklinik Freiburg Abt. Pneumologie
    • Mr.  Dr.  Stephan  Walterspacher 
    • Killianstr. 5
    • 79106   Freiburg
    • Germany
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    • Uniklinik Freiburg Abt. Pneumologie
    • Mr.  Dr.  Stephan  Walterspacher 
    • Killianstr. 5
    • 79106   Freiburg
    • Germany
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    • Uniklinik Freiburg Abt. Onkologie
    • Mr.  Dr.  Holger  Kiesel 
    • Killainstr. 5
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Weinmann Geräte für Medizin GmbH + Co. KG
    • 22525   Hamburg
    • Germany
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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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Status

  •   Recruiting stopped after recruiting started
  •   2013/10/09
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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.