Trial document




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  DRKS00015496

Trial Description

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Title

Sleep quality following initiation of NIV in chronic hyperkapnic COPD

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The study is focussing investigation sleep quality before and after initiation of noninvasive ventilation (NIV) in patients suffering from COPD. In addition the study investigates effects on respiratory events, lung function and health related quality of life. Furthermore, a subgroup analysis is planned regarding the co-morbidity of obstructive sleep apnea.

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Brief Summary in Scientific Language

The study is focussing investigation sleep quality before and after initiation of noninvasive ventilation (NIV) in patients suffering from COPD. Primary endpoint is REM-Sleep after a period of 3 month home NIV. In addition the study investigates effects on respiratory events, lung function and health related quality of life. Furthermore, a subgroup analysis is planned regarding the co-morbidity of obstructive sleep apnea.

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Organizational Data

  •   DRKS00015496
  •   2018/09/10
  •   [---]*
  •   yes
  •   Approved
  •   18038, Ethik-Kommission der Bayerischen Landesärztekammer
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Secondary IDs

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

  •   J44.9 -  Chronic obstructive pulmonary disease, unspecified
  •   J96.1 -  Chronic respiratory failure
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Interventions/Observational Groups

  •   Sleep quality will be assed at baseline and following 3 months of noninvasive ventilation (NIV). In addition lung function and gas exchange as well as health related quality of life will be assessed prior NIV initiation and following 3 months of NIV. A subgroup analysis of the investigations is planned in regard of the presence of obstructive sleep apnea syndrome or not.
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Characteristics

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

Rapid-Eye-Movement (REM)-sleep assessed by polysomnography at baseline and following 3 months of home NIV.

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Secondary Outcome

Accordingly to primary endpoint results of polysomnography, lung function, gas exchange and quality of life will be assessed at baseline and following 3 months of home NIV.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2018/11/12
  •   35
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Indication for home NIV in COPD following national guidelines

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Exclusion Criteria

recent acute respiratory failure with hospital admission in the last 4 weeks, NIV-users

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Asklepios Fachkliniken München-Gauting Abteilung für Intensiv-, Schlaf- und Beatmungsmedizin
    • Mr.  Professor  Jan Hendrik  Storre 
    • Robert-Koch-Allee 2
    • 82131  Gauting
    • Germany
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    •   +49 (89) 85791-4301
    •   +49 (89) 85791-4306
    •   [---]*
    •   [---]*
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  • start of 1:1-Block address scientific-contact
    • Asklepios Fachkliniken München-Gauting Abteilung für Intensiv-, Schlaf- und Beatmungsmedizin
    • Mr.  Professor  Jan Hendrik  Storre 
    • Robert-Koch-Allee 2
    • 82131  Gauting
    • Germany
    end of 1:1-Block address scientific-contact
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    • Asklepios Fachkliniken München-Gauting Abteilung für Intensiv-, Schlaf- und Beatmungsmedizin
    • Mr.  Professor  Jan Hendrik  Storre 
    • Robert-Koch-Allee 2
    • 82131  Gauting
    • Germany
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    end of 1:1-Block address contact public-contact
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Sources of Monetary or Material Support

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    • Asklepios Fachkliniken München-Gauting Abteilung für Intensiv-, Schlaf- und Beatmungsmedizin
    • Mr.  Professor  Jan Hendrik  Storre 
    • Robert-Koch-Allee 2
    • 82131  Gauting
    • Germany
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    •   +49 (89) 85791-4301
    •   +49 (89) 85791-4306
    •   [---]*
    •   [---]*
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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.