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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
Krankenhaus Kloster Grafschaft
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
May 25, 2012
Last Updated
January 6, 2016
Sponsor
Krankenhaus Kloster Grafschaft
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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

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Bilevel Versus Servoventilation in Complex Sleep Apnea

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