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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Krankenhaus Kloster Grafschaft.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Dominic Dellweg, M.D., Krankenhaus Kloster Grafschaft
ClinicalTrials.gov Identifier:
NCT01609244
First received: May 25, 2012
Last updated: May 29, 2012
Last verified: May 2012

May 25, 2012
May 29, 2012
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
  • 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.
 
Recruiting
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
No
Contact: Dominic Dellweg, MD +49 151 555 66088 ddellweg@freenet.de
Germany
 
NCT01609244
CSA-2010
No
Dominic Dellweg, M.D., Krankenhaus Kloster Grafschaft
Krankenhaus Kloster Grafschaft
Not Provided
Not Provided
Krankenhaus Kloster Grafschaft
May 2012

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