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Randomized trial to evaluate the performance of Bilevel vs. Servoventilation in patients with complex sleep apnea during continuous positive airway pressure (CPAP) treatment.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bilevel | Active Comparator | Bilevel therapy |
|
| Servoventilation | Active Comparator | servoventilation therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilevel therapy (somnovent ST 22, Weinmann, Hamburg, Germany) | Device | nighttime positive airway therapy for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| apnea-hypopnea index | apneas and hypopneas under therapy | at 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage slow wave sleep, percentage rapid eye movement (REM) sleep, Arousal index, sleep time, sleep efficacy | parameters of sleep quality | at 6 weeks |
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Inclusion Criteria:
Predominant obstructive apnea without treatment Predominant central apnea with CPAP treatment
Exclusion Criteria:
primary central sleep apnea non-compliance to CPAP therapy
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| Name | Affiliation | Role |
|---|---|---|
| Dominic Dellweg, MD | FKKG | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kloster Grafschaft | Schmallenberg | North Rhine-Westphalia | 57392 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17874254 | Background | 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. | |
| 23904676 | Derived | 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. |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D020182 | Sleep Apnea, Central |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| servoventilation (Somnovent CR, Weinmann, Hamburg, Germany) | Device | nighttime positive airway therapy for 6 weeks |
|
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |