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Completed

NCT Number: NCT00262366

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

Comparison of automatic CPAP with fixed CPAP in patients with OSAS

Completed

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Key information

Conditions

Obstructive Sleep Apnea Syndrome Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ghent

Ghent, 9000, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comparison of automatic CPAP versus fixed CPAP

Device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

Titration Efficacy of Automatic CPAP Versus Fixed CPAP, Following a Prediction Formula in Patients With OSAS

Important dates

Study start
2005
Study completion
2006
First posted
Dec 6, 2005
Registry last updated
Dec 28, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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