Oxidative Stress and Endothelial Dysfunction in Obstructive Sleep Apnea

NCT ID: NCT00646971

Last Updated: 2010-07-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2010-04-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

CPAP

Group Type: EXPERIMENTAL

CPAP device

Intervention Type: DEVICE

for 4 weeks

2

sham CPAP

Group Type: SHAM_COMPARATOR

Placebo device

Intervention Type: DEVICE

for 4 weeks

Interventions

CPAP device

for 4 weeks

Intervention Type: DEVICE

Placebo device

for 4 weeks

Intervention Type: DEVICE

Other Intervention Names

CPAP; Placebo

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Departement Clinical Research of Developpement

Principal Investigators

Pierre ESCOURROU, MD, PhD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère

Gabriel ROISMAN, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris, Hôpital Antoine Béclère

Locations

Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère

Clamart, , France

Countries

France

Other Identifiers

P041012

Identifier Type: -

Identifier Source: org_study_id