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
  Purpose

Randomized trial to evaluate the performance of Bilevel vs. Servoventilation in patients with complex sleep apnea during continuous positive airway pressure (CPAP) treatment.


Condition Intervention
Complex Sleep Apnea
Device: Bilevel therapy (somnovent ST 22, Weinmann, Hamburg, Germany)
Device: servoventilation (Somnovent CR, Weinmann, Hamburg, Germany)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Bilevel Versus Servoventilation in Complex Sleep Apnea

Resource links provided by NLM:


Further study details as provided by Krankenhaus Kloster Grafschaft:

Primary Outcome Measures:
  • apnea-hypopnea index [ Time Frame: at 6 weeks ] [ Designated as safety issue: No ]
    apneas and hypopneas under therapy


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 30
Study Start Date: January 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bilevel
Bilevel therapy
Device: Bilevel therapy (somnovent ST 22, Weinmann, Hamburg, Germany)
nighttime positive airway therapy for 6 weeks
Active Comparator: Servoventilation
servoventilation therapy
Device: servoventilation (Somnovent CR, Weinmann, Hamburg, Germany)
nighttime positive airway therapy for 6 weeks

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01609244

Contacts
Contact: Dominic Dellweg, MD +49 151 555 66088 ddellweg@freenet.de

Locations
Germany
Kloster Grafschaft Recruiting
Schmallenberg, NRW, Germany, 57392
Contact: Dominic Dellweg       ddellweg@freenet.de   
Principal Investigator: Dominic Dellweg, MD         
Sub-Investigator: Ekkehard Hoehn         
Sponsors and Collaborators
Krankenhaus Kloster Grafschaft
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dominic Dellweg, M.D., Attending physician sleep laboratoy and home mechanical ventilation unit, Krankenhaus Kloster Grafschaft
ClinicalTrials.gov Identifier: NCT01609244     History of Changes
Other Study ID Numbers: CSA-2010
Study First Received: May 25, 2012
Last Updated: May 29, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Krankenhaus Kloster Grafschaft:
Sleep apnea
central sleep apnea
bilevel
servoventilation
CPAP

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on August 20, 2014