NCT00262366

Brief Summary

Comparison of automatic CPAP with fixed CPAP in patients with OSAS

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2005

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 6, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

December 28, 2007

Status Verified

December 1, 2007

First QC Date

December 4, 2005

Last Update Submit

December 19, 2007

Conditions

Obstructive Sleep Apnea Syndrome

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • 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

Interventions

Comparison of automatic CPAP versus fixed CPAPDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with proven Obstructive Sleep Apnea Syndrome
  • Apnea-hypopnea-index \> 20/h
  • Awaking index \> 30/h

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Dirk Pevernagie, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 4, 2005

First Posted

December 6, 2005

Study Start

May 1, 2005

Study Completion

March 1, 2006

Last Updated

December 28, 2007

Record last verified: 2007-12

Locations

BE(1)