COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Trial of Auto Continuous Positive Airway Pressure (CPAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01064258
Recruitment Status : Completed
First Posted : February 8, 2010
Last Update Posted : February 16, 2010
Cliniques universitaires Saint-Luc
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: CPAP Device: autoCPAP Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reliability of Automatic CPAP Devices. A Double Blind Dummy Controlled Phase 1 Study
Study Start Date : August 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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

Primary Outcome Measures :
  1. number of episodes of increases in applied positive pressure, duration of each episode, and maximal pressure attained [ Time Frame: one night ]

Secondary Outcome Measures :
  1. reasons for pressure increase and consequences of the increase on sleep continuity [ Time Frame: one night ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01064258

Layout table for location information
Cliniques universitaires Saint-Luc
Brussels, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Cliniques universitaires Saint-Luc
Layout table for investigator information
Principal Investigator: Daniel Rodenstein, MD Cliniques universitaires Saint-Luc
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Daniel Rodenstein MD, Cliniques universitaires Saint-Luc Identifier: NCT01064258    
Other Study ID Numbers: 2007/30MARS/67
First Posted: February 8, 2010    Key Record Dates
Last Update Posted: February 16, 2010
Last Verified: February 2010
Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
sleep apnea
Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases