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

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ClinicalTrials.gov Identifier: NCT01609244
Recruitment Status : Completed
First Posted : May 31, 2012
Last Update Posted : January 8, 2016
Sponsor:
Information provided by (Responsible Party):
Dominic Dellweg, M.D., Krankenhaus Kloster Grafschaft

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.

Condition or disease Intervention/treatment Phase
Complex Sleep Apnea CPAP Induced Central Sleep Apnea Device: Bilevel therapy (somnovent ST 22, Weinmann, Hamburg, Germany) Device: servoventilation (Somnovent CR, Weinmann, Hamburg, Germany) Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Bilevel Versus Servoventilation in Complex Sleep Apnea
Study Start Date : January 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. apnea-hypopnea index [ Time Frame: at 6 weeks ]
    apneas and hypopneas under therapy


Secondary Outcome Measures :
  1. Percentage slow wave sleep, percentage rapid eye movement (REM) sleep, Arousal index, sleep time, sleep efficacy [ Time Frame: at 6 weeks ]
    parameters of sleep quality



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01609244


Locations
Germany
Kloster Grafschaft
Schmallenberg, NRW, Germany, 57392
Sponsors and Collaborators
Krankenhaus Kloster Grafschaft
Investigators
Study Chair: Dominic Dellweg, MD FKKG

Publications:
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
First Posted: May 31, 2012    Key Record Dates
Last Update Posted: January 8, 2016
Last Verified: January 2016

Keywords provided by Dominic Dellweg, M.D., Krankenhaus Kloster Grafschaft:
Sleep apnea
central sleep apnea
bilevel
servoventilation
CPAP

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