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Trial of Auto Continuous Positive Airway Pressure (CPAP)

This study has been completed.
Sponsor:
Collaborator:
Cliniques universitaires Saint-Luc
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT01064258
First received: February 4, 2010
Last updated: February 15, 2010
Last verified: February 2010

February 4, 2010
February 15, 2010
August 2009
October 2009   (final data collection date for primary outcome measure)
number of episodes of increases in applied positive pressure, duration of each episode, and maximal pressure attained [ Time Frame: one night ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01064258 on ClinicalTrials.gov Archive Site
reasons for pressure increase and consequences of the increase on sleep continuity [ Time Frame: one night ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Trial of Auto Continuous Positive Airway Pressure (CPAP)
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Obstructive Sleep Apnea
  • Device: CPAP
    CPAP at 4 cm H2O
  • Device: autoCPAP
    autoCPAP working between 4 and 15 cm H2O
  • Active Comparator: fixed CPAP
    subject will sleep with a fixed CPAP device at minimal pressure
    Intervention: Device: CPAP
  • Experimental: autoCPAP
    the subject will sleep connected to an autoCPAP device
    Intervention: Device: autoCPAP
Mwenge GB, Dury M, Delguste P, Rodenstein D. Response of automatic continuous positive airway pressure devices in a normal subject. Eur Respir J. 2011 Jun;37(6):1530-3. doi: 10.1183/09031936.00139510.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1
October 2009
October 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01064258
2007/30MARS/67
No
Daniel Rodenstein MD, Cliniques universitaires Saint-Luc
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Cliniques universitaires Saint-Luc
Principal Investigator: Daniel Rodenstein, MD Cliniques universitaires Saint-Luc
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP