Oxidative Stress and Endothelial Dysfunction in Obstructive Sleep Apnea

Not Applicable

Terminated

• Conditions: Endothelial Dysfunction; Obstructive Sleep Apnea Syndrome; Oxidative Stress; Intermittent Hypoxia; Cardiovascular Risk
• Interventions: Device: CPAP device; Device: Placebo device

• Registration Number: NCT00646971
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-03-17
• Study First Submitted QC: 2008-03-28
• Study First Posted: 2008-03-31
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2010-05
• Last Update Submitted: 2010-07-09
• Last Update Posted: 2010-07-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	CPAP device	CPAP
2	Placebo device	sham CPAP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère; 🇫🇷 Clamart, France