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

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ClinicalTrials.gov Identifier: NCT00262366
Recruitment Status : Completed
First Posted : December 6, 2005
Last Update Posted : December 28, 2007
Sponsor:
Information provided by:
University Hospital, Ghent

Brief Summary:
Comparison of automatic CPAP with fixed CPAP in patients with OSAS

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Syndrome Device: Comparison of automatic CPAP versus fixed CPAP Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Titration Efficacy of Automatic CPAP Versus Fixed CPAP, Following a Prediction Formula in Patients With OSAS
Study Start Date : May 2005
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Respiratory control expressed by residual number of obstructive and central apneas, hypopneas and snoring
  2. Arousal index
  3. Pressure profile Auto-CPAP (P50, P95 en Pmax)
  4. All outcomes are measured during polysomnography

Secondary Outcome Measures :
  1. Pressure adaptation during polysomnography according to body position and sleep stage, pressure variability
  2. Measurements of comfort, subjective evaluation by the patient by questionnaires immediately after polysomnography


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
ClinicalTrials.gov Identifier: NCT00262366     History of Changes
Other Study ID Numbers: 2005/099
First Posted: December 6, 2005    Key Record Dates
Last Update Posted: December 28, 2007
Last Verified: December 2007

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases