Bilevel Versus Servoventilation in Complex Sleep Apnea

Complex Sleep Apnea Clinical Trial

— CSA-FKKG  

Official title:

Bilevel Versus Servoventilation in Complex Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01609244
• Other study ID #: CSA-2010
• Status: Completed
• Phase: N/A
• First received: May 25, 2012
• Last updated: January 6, 2016
• Start date: January 2010
• Est. completion date: July 2012

Study information

• Verified date: January 2016
• Source: Krankenhaus Kloster Grafschaft
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

Predominant obstructive apnea without treatment Predominant central apnea with CPAP treatment

Exclusion Criteria:

primary central sleep apnea non-compliance to CPAP therapy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Complex Sleep Apnea
• CPAP Induced Central Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Device:
• Bilevel therapy (somnovent ST 22, Weinmann, Hamburg, Germany)
nighttime positive airway therapy for 6 weeks
• servoventilation (Somnovent CR, Weinmann, Hamburg, Germany)
nighttime positive airway therapy for 6 weeks

Locations

Country	Name	City	State
Germany	Kloster Grafschaft	Schmallenberg	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Krankenhaus Kloster Grafschaft

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	apnea-hypopnea index	apneas and hypopneas under therapy	at 6 weeks	No
Secondary	Percentage slow wave sleep, percentage rapid eye movement (REM) sleep, Arousal index, sleep time, sleep efficacy	parameters of sleep quality	at 6 weeks	No