Oxidative Stress and Endothelial Dysfunction in Obstructive Sleep Apnea (SOREVAS)

Assistance Publique - Hôpitaux de Paris

Status: Terminated

Conditions: Intermittent Hypoxia; Endothelial Dysfunction; Obstructive Sleep Apnea Syndrome; Oxidative Stress; Cardiovascular Risk

Treatments: Device: CPAP device; Device: Placebo device

Study type: Interventional

Funder types: Other

Identifiers

NCT00646971

P041012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• No smoking
• 30-70 years old subjects
• being referred for daytime hyper- somnolence and snoring
• apnea hypopnea index >=30/hour and desaturation index>=30/hour

Exclusion criteria

• Chronic lung diseases.
• Exposure to occupational contaminants.
• Active smoking within last 2 years.
• Alcoholism.
• Chronic systemic disease other than OSAS.
• Treatment with vasoactive drugs or antioxidants
• Respiratory infection or vaccination during the 6 weeks preceding the PSG1.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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11 participants in 2 patient groups

1

Experimental group

Description:

CPAP

Treatment:

Device: CPAP device

2

Sham Comparator group

Description:

sham CPAP

Treatment:

Device: Placebo device