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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00262366
First received: December 4, 2005
Last updated: December 19, 2007
Last verified: December 2007
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Titration Efficacy of Automatic CPAP Versus Fixed CPAP, Following a Prediction Formula in Patients With OSAS

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

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

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

ClinicalTrials.gov processed this record on September 16, 2014