An interventional study of CPAP device and Placebo device in Obstructive Sleep Apnea Syndrome, Endothelial Dysfunction and Oxidative Stress, sponsored by Assistance Publique - Hôpitaux de Paris. Terminated at 1 site in France. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2010-07-12.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment
Patients with sleep apnea syndrome have repeated apneic events that induce periodic hypoxia-reoxygenation, drawing away an overproduction of oxidants. This exaggerated generation of oxidants is associated with a dysfunction of the vascular endothelium that evolves, in its turn, towards cardiovascular diseases such as systemic hypertension, stroke, and myocardial infarction. The major aim of our study is to examine the effect of CPAP treatment on biochemical (markers of oxidative stress) and functional (endothelium-dependent vascular relaxation reactivity) abnormalities at 1 and 4 weeks of treatment.
Subjects will undergo overnight polysomnography in the sleep laboratory (PSG1, D0), which will be immediately preceded and followed by measurements of oxidative stress in exhaled gas and vascular relaxation. Patients included in the OSAS group will be randomly assigned to treatment by either CPAP or Placebo (sham CPAP) for 4 weeks. Measurements of oxidative stress in exhaled gas and vascular reactivity will be repeated immediately before and after PSG2 and PSG3 at D7 and D30, respectively.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 11 is below the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
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Exclusion Criteria:
CPAP
Device: CPAP device
sham CPAP
Device: Placebo device
for 4 weeks
Also known as: CPAP
for 4 weeks
Also known as: Placebo
To examine the effect of CPAP treatment on biochemical (markers of oxidative stress) abnormalities
Time frame: 1 and 4 weeks of treatment
To compare between patients with severe OSAS and controls, the degree of the production of markers of oxidative stress non-invasively measured in both the exhaled gas and urine samples
Time frame: before and after a nocturnal polysomnography
To compare between patients and controls, the endothelium-dependent vascular relaxation
Time frame: before and after nocturnal polysomnography
To analyze the relationship between these biochemical and functional abnormalities and the standard criteria of severity of OSAS.
Time frame: before and after nocturnal polysomnography
To examine the effect of CPAP treatment on functional (endothelium-dependent vascular relaxation reactivity) abnormalities
Time frame: 1 and 4 weeks of treatment
This study is terminated, as verified in May 2010. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris