Bilevel Versus Servoventilation in Complex Sleep Apnea (CSA-FKKG)
Primary Purpose
Complex Sleep Apnea, CPAP Induced Central Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Bilevel therapy (somnovent ST 22, Weinmann, Hamburg, Germany)
servoventilation (Somnovent CR, Weinmann, Hamburg, Germany)
Sponsored by
About this trial
This is an interventional treatment trial for Complex Sleep Apnea focused on measuring Sleep apnea, central sleep apnea, bilevel, servoventilation, CPAP
Eligibility Criteria
Inclusion Criteria:
Predominant obstructive apnea without treatment Predominant central apnea with CPAP treatment
Exclusion Criteria:
primary central sleep apnea non-compliance to CPAP therapy
Sites / Locations
- Kloster Grafschaft
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Bilevel
Servoventilation
Arm Description
Bilevel therapy
servoventilation therapy
Outcomes
Primary Outcome Measures
apnea-hypopnea index
apneas and hypopneas under therapy
Secondary Outcome Measures
Percentage slow wave sleep, percentage rapid eye movement (REM) sleep, Arousal index, sleep time, sleep efficacy
parameters of sleep quality
Full Information
NCT ID
NCT01609244
First Posted
May 25, 2012
Last Updated
January 6, 2016
Sponsor
Krankenhaus Kloster Grafschaft
1. Study Identification
Unique Protocol Identification Number
NCT01609244
Brief Title
Bilevel Versus Servoventilation in Complex Sleep Apnea
Acronym
CSA-FKKG
Official Title
Bilevel Versus Servoventilation in Complex Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Krankenhaus Kloster Grafschaft
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Randomized trial to evaluate the performance of Bilevel vs. Servoventilation in patients with complex sleep apnea during continuous positive airway pressure (CPAP) treatment.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Sleep Apnea, CPAP Induced Central Sleep Apnea
Keywords
Sleep apnea, central sleep apnea, bilevel, servoventilation, CPAP
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bilevel
Arm Type
Active Comparator
Arm Description
Bilevel therapy
Arm Title
Servoventilation
Arm Type
Active Comparator
Arm Description
servoventilation therapy
Intervention Type
Device
Intervention Name(s)
Bilevel therapy (somnovent ST 22, Weinmann, Hamburg, Germany)
Intervention Description
nighttime positive airway therapy for 6 weeks
Intervention Type
Device
Intervention Name(s)
servoventilation (Somnovent CR, Weinmann, Hamburg, Germany)
Intervention Description
nighttime positive airway therapy for 6 weeks
Primary Outcome Measure Information:
Title
apnea-hypopnea index
Description
apneas and hypopneas under therapy
Time Frame
at 6 weeks
Secondary Outcome Measure Information:
Title
Percentage slow wave sleep, percentage rapid eye movement (REM) sleep, Arousal index, sleep time, sleep efficacy
Description
parameters of sleep quality
Time Frame
at 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Predominant obstructive apnea without treatment Predominant central apnea with CPAP treatment
Exclusion Criteria:
primary central sleep apnea non-compliance to CPAP therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominic Dellweg, MD
Organizational Affiliation
FKKG
Official's Role
Study Chair
Facility Information:
Facility Name
Kloster Grafschaft
City
Schmallenberg
State/Province
NRW
ZIP/Postal Code
57392
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
17874254
Citation
Kuzniar TJ, Pusalavidyasagar S, Gay PC, Morgenthaler TI. Natural course of complex sleep apnea--a retrospective study. Sleep Breath. 2008 May;12(2):135-9. doi: 10.1007/s11325-007-0140-z.
Results Reference
background
PubMed Identifier
23904676
Citation
Dellweg D, Kerl J, Hoehn E, Wenzel M, Koehler D. Randomized controlled trial of noninvasive positive pressure ventilation (NPPV) versus servoventilation in patients with CPAP-induced central sleep apnea (complex sleep apnea). Sleep. 2013 Aug 1;36(8):1163-71. doi: 10.5665/sleep.2878.
Results Reference
derived
Learn more about this trial
Bilevel Versus Servoventilation in Complex Sleep Apnea
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