Trial of Auto Continuous Positive Airway Pressure (CPAP)

February 15, 2010 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-Luc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: fixed CPAP
subject will sleep with a fixed CPAP device at minimal pressure
Device: CPAP
CPAP at 4 cm H2O
Experimental: autoCPAP
the subject will sleep connected to an autoCPAP device
Device: autoCPAP
autoCPAP working between 4 and 15 cm H2O

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of episodes of increases in applied positive pressure, duration of each episode, and maximal pressure attained
Time Frame: one night
one night

Secondary Outcome Measures

Outcome Measure
Time Frame
reasons for pressure increase and consequences of the increase on sleep continuity
Time Frame: one night
one night

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Collaborators

Cliniques universitaires Saint-Luc

Investigators

  • Principal Investigator: Daniel Rodenstein, MD, Cliniques Universitaires Saint-Luc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

February 4, 2010

First Submitted That Met QC Criteria

February 5, 2010

First Posted (Estimate)

February 8, 2010

Study Record Updates

Last Update Posted (Estimate)

February 16, 2010

Last Update Submitted That Met QC Criteria

February 15, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007/30MARS/67

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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