Complex Sleep Apnea, CPAP Induced Central Sleep Apnea
Conditions
Keywords
Sleep apnea, central sleep apnea, bilevel, servoventilation, CPAP
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.
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.
Interventions
DEVICEBilevel therapy (somnovent ST 22, Weinmann, Hamburg, Germany)
nighttime positive airway therapy for 6 weeks
DEVICEservoventilation (Somnovent CR, Weinmann, Hamburg, Germany)
nighttime positive airway therapy for 6 weeks
Sponsors
Krankenhaus Kloster Grafschaft
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| apnea-hypopnea index | at 6 weeks | apneas and hypopneas under therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage slow wave sleep, percentage rapid eye movement (REM) sleep, Arousal index, sleep time, sleep efficacy | at 6 weeks | parameters of sleep quality |
Countries
Germany
Outcome results
None listed