Comparison of Automatic CPAP to Fixed CPAP for OSAS Following a Prediction Formula
Not Applicable
Completed
- Conditions
- Obstructive Sleep Apnea Syndrome
- Registration Number
- NCT00262366
- Lead Sponsor
- University Hospital, Ghent
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
University Hospital Ghent
🇧🇪Ghent, Belgium