Skip to main content
OpenTrials
Completed

NCT Number: NCT01064258

Trial of Auto Continuous Positive Airway Pressure (CPAP)

Background: In patients with obstructive sleep apnea, automatic continuous positive airway pressure machines (autoCPAP) are said to be capable of identifying various breathing abnormalities during sleep and to correct them by increasing progressively the positive pressure applied to the airway. Once breathing becomes normal, pressure slowly declines. AutoCPAP devices have never been tested in Phase I studies. The investigators hypothesised that normal breathing would not be recognised as such, and that pressure would increase even in a normal subject.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obstructive Sleep Apnea 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–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

About this study

Material and Methods: We will submit one normal (confirmed with two polysomnographies, PSG) subject to a double blind study. Pairs of PSG will be performed on successive days once a week, one night with a 4 cm water fixed pressure CPAP device, previously shown not to disturb the subject's sleep and breathing, the other night with one of five well known autoCPAP devices programmed to work between 4 and 15 cm H2O pressure. The same mask and headgear will be used throughout the study. The subject and the physicians reading the tracings will ignore which device is being used on which night.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • normal subject
  • male and female
  • age 18 to 65 years old

Exclusion criteria

  • obstructive sleep apnea
  • unable to sleep with a CPAP device

Treatment and study plan

CPAP

Device

CPAP at 4 cm H2O

AutoCPAP

Device

autoCPAP working between 4 and 15 cm H2O

Primary outcomes

  1. number of episodes of increases in applied positive pressure, duration of each episode, and maximal pressure attained

    Time frame: one night

Secondary outcomes

  1. reasons for pressure increase and consequences of the increase on sleep continuity

    Time frame: one night

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

Reliability of Automatic CPAP Devices. A Double Blind Dummy Controlled Phase 1 Study

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 8, 2010
Registry last updated
Feb 16, 2010

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.