Titration Efficacy of Automatic CPAP Versus Fixed CPAP, Following a Prediction Formula in Patients With OSAS

University Hospital, Ghent1 site in 1 country45 target enrollmentMay 2005

ConditionsObstructive Sleep Apnea Syndrome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Obstructive Sleep Apnea Syndrome
Sponsor: University Hospital, Ghent
Enrollment: 45
Locations: 1
Primary Endpoint: Respiratory control expressed by residual number of obstructive and central apneas, hypopneas and snoring
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

May 2005

End Date

March 2006

Last Updated

18 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

University Hospital, Ghent

Eligibility Criteria

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

Outcomes

Primary Outcomes

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 Outcomes

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