Trial document





This trial has been registered retrospectively.
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  DRKS00000520

Trial Description

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Title

Quality of sleep during noninvasive positive pressure ventilation with high inspiratory pressures in patients with stable hypercapnic COPD

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Compare sleep quality between noninvasive ventilation with high and low inspiratory pressure druing two consecutive nights. To investigate if there are differences in sleep quality during noninvasive ventilation with high and low inspiratory pressures.

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Brief Summary in Scientific Language

Compare sleep quality between high- and low-intensity noninvasive positive pressure ventilation in patients suffering from COPD GOLD stage IV and home mechanical ventilation. The aim is to investigate sleep quality during noninvasive ventilation with high inspiratory pressures and to investigate differences between high and low pressures

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Organizational Data

  •   DRKS00000520
  •   2010/10/05
  •   2008/03/23
  •   yes
  •   Approved
  •   17/08, Ethik-Kommission der Albert-Ludwig-Universität Freiburg
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Secondary IDs

  •   UKF001499  (Register klinischer Studien des Universitätsklinikums Freiburg)
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Health Condition or Problem studied

  •   J44.89 -  [generalization J44.8: Other specified chronic obstructive pulmonary disease]
  •   [---]* -  [---]*
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Interventions/Observational Groups

  •   high-intensity noninvasive positive pressure ventilation (pressure controlled ventilation with high inspiratory pressures)
  •   noninvasive positive pressure ventilation with low inspiratory pressures
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Treatment
  •   Crossover
  •   N/A
  •   [---]*
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Primary Outcome

Polysomnographic assessment of NREM sleep stage 3 and 4 during nighttime noninvasive ventilation

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Secondary Outcome

Polysomnographic assessment of REM sleep, blod gas analysis; both assessed during nighttime noninvasive ventilation

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2008/02/10
  •   13
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
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Additional Inclusion Criteria

COPD GOLD stage IV with home mechanical ventilation

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Exclusion Criteria

acute exazerbation

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Abteilung Pneumologie, Universitätsklinik Freiburg
    • Mr.  Dr. med.   Michael  Dreher 
    • Killianstrasse 5
    • 79106  Freiburg
    • Germany
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    •   [---]*
    •   [---]*
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    • Abteilung Pneumologie, Universitätsklinik Freiburg
    • Mr.  Dr. med.   Michael  Dreher 
    • Killianstrasse 5
    • 79106  Freiburg
    • Germany
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    end of 1:1-Block address contact scientific-contact
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    • Abteilung Pneumologie, Universitätsklinik Freiburg
    • Mr.  Dr. med.   Michael  Dreher 
    • Killianstrasse 5
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Abteilung Pneumologie, Universitätsklinik Freiburg
    • Mr.  Dr. med.   Michael  Dreher 
    • Killianstrasse 5
    • 79106  Freiburg
    • Germany
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    •   [---]*
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2010/08/05
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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.