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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00646971

Acronym

SOREVAS

Enrollment

Registered

2008-03-31

Start date

2008-01-31

Completion date

2010-04-30

Last updated

2010-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

DEVICECPAP device

for 4 weeks

DEVICEPlacebo device

for 4 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

30 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame
To examine the effect of CPAP treatment on biochemical (markers of oxidative stress) abnormalities	1 and 4 weeks of treatment

Secondary

Measure	Time frame
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	before and after a nocturnal polysomnography
To compare between patients and controls, the endothelium-dependent vascular relaxation	before and after nocturnal polysomnography
To analyze the relationship between these biochemical and functional abnormalities and the standard criteria of severity of OSAS.	before and after nocturnal polysomnography
To examine the effect of CPAP treatment on functional (endothelium-dependent vascular relaxation reactivity) abnormalities	1 and 4 weeks of treatment

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026