CSA-FKKG: Bilevel Versus Servoventilation in Complex Sleep Apnea

• Sponsor: Krankenhaus Kloster Grafschaft (Other)
• Overall Status: Completed
• CT.gov ID: NCT01609244
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 30
• Patients Per Site Per Month: 1

Study Details

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.

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)	N/A

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 Design

• Study Type: Interventional
• 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: Jan 1, 2010
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Jul 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. apnea-hypopnea index [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 [at 6 weeks]

   parameters of sleep quality

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Kloster Grafschaft	Schmallenberg	NRW	Germany	57392

Sponsors and Collaborators

• Krankenhaus Kloster Grafschaft

Investigators

• Study Chair: Dominic Dellweg, MD, FKKG

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Dominic Dellweg, M.D., Attending physician sleep laboratoy and home mechanical ventilation unit, Krankenhaus Kloster Grafschaft
• ClinicalTrials.gov Identifier: NCT01609244
• Other Study ID Numbers: CSA-2010
• First Posted: May 31, 2012
• Last Update Posted: Jan 8, 2016
• Last Verified: Jan 1, 2016

• Keywords provided by Dominic Dellweg, M.D., Attending physician sleep laboratoy and home mechanical ventilation unit, Krankenhaus Kloster Grafschaft: Sleep apnea; central sleep apnea; bilevel; servoventilation; CPAP
• Additional relevant MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Central

Study Results

No Results Posted as of Jan 8, 2016