Bilevel Versus Servoventilation in Complex Sleep Apnea (CSA-FKKG)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dominic Dellweg, M.D., Krankenhaus Kloster Grafschaft
ClinicalTrials.gov Identifier:
NCT01609244
First received: May 25, 2012
Last updated: January 6, 2016
Last verified: January 2016

May 25, 2012
January 6, 2016
January 2010
June 2012   (final data collection date for primary outcome measure)
apnea-hypopnea index [ Time Frame: at 6 weeks ] [ Designated as safety issue: No ]
apneas and hypopneas under therapy
Same as current
Complete list of historical versions of study NCT01609244 on ClinicalTrials.gov Archive Site
Percentage slow wave sleep, percentage rapid eye movement (REM) sleep, Arousal index, sleep time, sleep efficacy [ Time Frame: at 6 weeks ] [ Designated as safety issue: No ]
parameters of sleep quality
Same as current
Not Provided
Not Provided
 
Bilevel Versus Servoventilation in Complex Sleep Apnea
Bilevel Versus Servoventilation in Complex Sleep Apnea
Randomized trial to evaluate the performance of Bilevel vs. Servoventilation in patients with complex sleep apnea during continuous positive airway pressure (CPAP) treatment.
Patients with primary obstructive sleep apnea, who develop complex sleep apnea after CPAP treatment of 4-6 weeks duration were randomized to either receive Bilevel of Servoventilation treatment. Parameters of sleep as well as apnea-hypopnea indices are to be compared.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Complex Sleep Apnea
  • CPAP Induced Central Sleep Apnea
  • Device: Bilevel therapy (somnovent ST 22, Weinmann, Hamburg, Germany)
    nighttime positive airway therapy for 6 weeks
  • Device: servoventilation (Somnovent CR, Weinmann, Hamburg, Germany)
    nighttime positive airway therapy for 6 weeks
  • Active Comparator: Bilevel
    Bilevel therapy
    Intervention: Device: Bilevel therapy (somnovent ST 22, Weinmann, Hamburg, Germany)
  • Active Comparator: Servoventilation
    servoventilation therapy
    Intervention: Device: servoventilation (Somnovent CR, Weinmann, Hamburg, Germany)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
July 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

Predominant obstructive apnea without treatment Predominant central apnea with CPAP treatment

Exclusion Criteria:

primary central sleep apnea non-compliance to CPAP therapy

Both
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01609244
CSA-2010
No
Not Provided
Not Provided
Dominic Dellweg, M.D., Krankenhaus Kloster Grafschaft
Krankenhaus Kloster Grafschaft
Not Provided
Study Chair: Dominic Dellweg, MD FKKG
Krankenhaus Kloster Grafschaft
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP