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NCT00262366 Clinical Trial

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

Obstructive Sleep Apnea Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00262366
Other study ID # 2005/099
Secondary ID
Status Completed
Phase N/A
First received December 4, 2005
Last updated December 19, 2007
Start date May 2005
Est. completion date March 2006

Study information
Verified date December 2007
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Comparison of automatic CPAP with fixed CPAP in patients with OSAS

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 information / eligibility
Status Completed
Enrollment 45
Est. completion date March 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Comparison of automatic CPAP versus fixed CPAP

Locations
Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Respiratory control expressed by residual number of obstructive and central apneas, hypopneas and snoring
Primary Arousal index
Primary Pressure profile Auto-CPAP (P50, P95 en Pmax)
Primary All outcomes are measured during polysomnography
Secondary Pressure adaptation during polysomnography according to body position and sleep stage, pressure variability
Secondary Measurements of comfort, subjective evaluation by the patient by questionnaires immediately after polysomnography
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