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Comparison of Automatic CPAP to Fixed CPAP for OSAS Following a Prediction Formula
This study has been completed.
Sponsored by: University Hospital, Ghent
Information provided by: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00262366
  Purpose

Comparison of automatic CPAP with fixed CPAP in patients with OSAS


Condition Intervention
Obstructive Sleep Apnea Syndrome
 Device: Comparison of automatic CPAP versus fixed CPAP

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Efficacy Study
Official Title: Titration Efficacy of Automatic CPAP Versus Fixed CPAP, Following a Prediction Formula in Patients With OSAS

Further study details as provided by University Hospital, Ghent:

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

Estimated Enrollment: 45
Study Start Date: May 2005
Study Completion Date: March 2006
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00262366

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Dirk Pevernagie, MD, PhD University Hospital, Ghent
  More Information

Website of the University Hospital Ghent  This link exits the ClinicalTrials.gov site

Study ID Numbers: 2005/099
Study First Received: December 4, 2005
Last Updated: December 19, 2007
ClinicalTrials.gov Identifier: NCT00262366  
Health Authority: Belgium: Institutional Review Board

Study placed in the following topic categories:
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Respiration Disorders
 Sleep Apnea, Obstructive
Dyssomnias
Sleep Disorders
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:
Pathologic Processes
Disease
Syndrome
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009



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