Clinical Trials Directory

Trials / Terminated

TerminatedNCT00646971

Oxidative Stress and Endothelial Dysfunction in Obstructive Sleep Apnea

Exhaled Markers of Oxidative Stress and Endothelium-dependent Vascular Relaxation in Obstructive Sleep Apnea. Effect of Continuous Positive Airway Pressure Therapy.

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
11 (actual)
Sponsor
Assistance Publique - Hôpitaux de Paris · Academic / Other
Sex
All
Age
30 Years – 70 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DEVICECPAP devicefor 4 weeks
DEVICEPlacebo devicefor 4 weeks

Timeline

Start date
2008-01-01
Primary completion
2010-04-01
Completion
2010-04-01
First posted
2008-03-31
Last updated
2010-07-12

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT00646971. Inclusion in this directory is not an endorsement.