Comparison of Automatic CPAP to Fixed CPAP for OSAS Following a Prediction Formula

Ghent University Hospital (UZ)

Status: Completed

Conditions: Obstructive Sleep Apnea Syndrome

Treatments: Device: Comparison of automatic CPAP versus fixed CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT00262366

2005/099

Details and patient eligibility

About

Comparison of automatic CPAP with fixed CPAP in patients with OSAS

Full 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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind