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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2006-03-31

Brief Summary

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Comparison of automatic CPAP with fixed CPAP in patients with OSAS

Detailed Description

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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

Conditions

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Obstructive Sleep Apnea Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Comparison of automatic CPAP versus fixed CPAP

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Dirk Pevernagie, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2005/099

Identifier Type: -

Identifier Source: org_study_id