Clinical trial NCT00646971: Oxidative Stress and Endothelial Dysfunction in Obstructive Sleep Apnea
Official title: Exhaled Markers of Oxidative Stress and Endothelium-dependent Vascular Relaxation in Obstructive Sleep Apnea. Effect of Continuous Positive Airway Pressure Therapy.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obstructive Sleep Apnea Syndrome
Endothelial Dysfunction
Oxidative Stress
Intermittent Hypoxia
Cardiovascular Risk
Keywords: Isoprostane
Alkane
Exhaled condensate
Peripheral arterial tonometry
Polysomnography
Obstructive Sleep Apnea
Hypoxia
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2008-03-31
Enrollment: 11
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: To examine the effect of CPAP treatment on biochemical (markers of oxidative stress) abnormalities
timeFrame: 1 and 4 weeks of treatment
Secondary outcomes:
measure: 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
timeFrame: before and after a nocturnal polysomnography
measure: To compare between patients and controls, the endothelium-dependent vascular relaxation
timeFrame: before and after nocturnal polysomnography
measure: To analyze the relationship between these biochemical and functional abnormalities and the standard criteria of severity of OSAS.
timeFrame: before and after nocturnal polysomnography
measure: To examine the effect of CPAP treatment on functional (endothelium-dependent vascular relaxation reactivity) abnormalities
timeFrame: 1 and 4 weeks of treatment
Other outcomes:
Locations:
city: Clamart
country: France
facility: Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère
name: Pierre ESCOURROU, MD, PhD
role: STUDY_DIRECTOR
affiliation: Assistance Publique - Hôpitaux de Paris, Hôpital Antoine Béclère
name: Gabriel ROISMAN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: