Obstructive Sleep Apnea Syndrome
Conditions
Brief summary
Comparison of automatic CPAP with fixed CPAP in patients with OSAS
Detailed description
The polysomnography is divided into two parts, randomly assigned: * in one part, the patient uses the automatic CPAP device in titration mode * in the other part, the patient uses the CPAP device, in fixed mode according to the prediction formula
Interventions
DEVICEComparison of automatic CPAP versus fixed CPAP
Sponsors
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with proven Obstructive Sleep Apnea Syndrome * Apnea-hypopnea-index \> 20/h * Awaking index \> 30/h
Exclusion criteria
* Severe nasal obstruction * Hypoventilation * Excessive sleep fragmentation caused by non-respiratory factors * COPD (FEV1/FVC \< 65%) * CPAP compliance \< 3h per night * Insufficient sleep time (\< 2h TST) during one of both parts of the split night CPAP-titration * Patients needing \> 16 mbar CPAP pressures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Respiratory control expressed by residual number of obstructive and central apneas, hypopneas and snoring | — |
| Arousal index | — |
| Pressure profile Auto-CPAP (P50, P95 en Pmax) | — |
| All outcomes are measured during polysomnography | — |
Secondary
| Measure | Time frame |
|---|---|
| Pressure adaptation during polysomnography according to body position and sleep stage, pressure variability | — |
| Measurements of comfort, subjective evaluation by the patient by questionnaires immediately after polysomnography | — |
Countries
Belgium
Outcome results
None listed