A Phase 1 interventional study of CPAP and autoCPAP in Obstructive Sleep Apnea, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Completed at 1 site in Belgium. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-02-16.
Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Phase 1, Interventional, and Treatment
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.
2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 290 are open to participants now.
This study's enrollment of 1 is below the median of 53 across 1,386 interventional studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →Cliniques universitaires Saint-Luc- Université Catholique de Louvain is the lead sponsor of 342 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
subject will sleep with a fixed CPAP device at minimal pressure
Device: CPAP
the subject will sleep connected to an autoCPAP device
Device: autoCPAP
CPAP at 4 cm H2O
autoCPAP working between 4 and 15 cm H2O
number of episodes of increases in applied positive pressure, duration of each episode, and maximal pressure attained
Time frame: one night
reasons for pressure increase and consequences of the increase on sleep continuity
Time frame: one night
This study is completed, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.
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Cliniques universitaires Saint-Luc- Université Catholique de Louvain