Back to resultsComparison of Automatic CPAP to Fixed CPAP for OSAS Following a Prediction Formula
Primary Purpose
Obstructive Sleep Apnea Syndrome
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Comparison of automatic CPAP versus fixed CPAP
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea Syndrome
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
Sites / Locations
- University Hospital Ghent
Outcomes
Primary Outcome Measures
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
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
Full Information
NCT ID
NCT00262366
First Posted
December 4, 2005
Last Updated
December 19, 2007
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT00262366
Brief Title
Comparison of Automatic CPAP to Fixed CPAP for OSAS Following a Prediction Formula
Official Title
Titration Efficacy of Automatic CPAP Versus Fixed CPAP, Following a Prediction Formula in Patients With OSAS
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
45 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Comparison of automatic CPAP versus fixed CPAP
Primary Outcome Measure Information:
Title
Respiratory control expressed by residual number of obstructive and central apneas, hypopneas and snoring
Title
Arousal index
Title
Pressure profile Auto-CPAP (P50, P95 en Pmax)
Title
All outcomes are measured during polysomnography
Secondary Outcome Measure Information:
Title
Pressure adaptation during polysomnography according to body position and sleep stage, pressure variability
Title
Measurements of comfort, subjective evaluation by the patient by questionnaires immediately after polysomnography
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirk Pevernagie, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
Website of the University Hospital Ghent
Learn more about this trial
Comparison of Automatic CPAP to Fixed CPAP for OSAS Following a Prediction Formula
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