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

Exhaled Markers of Oxidative Stress and Endothelium-dependent Vascular Relaxation in Obstructive Sleep Apnea. Effect of Continuous Positive Airway Pressure Therapy.

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.

Study Overview

• Status: Terminated
• Conditions: Obstructive Sleep Apnea Syndrome; Endothelial Dysfunction; Oxidative Stress; Intermittent Hypoxia; Cardiovascular Risk
• Intervention / Treatment: Device: CPAP device; Device: Placebo device

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 Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clamart, France, 92141
    • Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; CPAP	Device: CPAP device; for 4 weeks; Other Names: CPAP
Sham Comparator: 2; sham CPAP	Device: Placebo device; for 4 weeks; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Director: Pierre ESCOURROU, MD, PhD, Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère; Principal Investigator: Gabriel ROISMAN, MD, PhD, Assistance Publique - Hopitaux de Paris, Hôpital Antoine Beclere

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: March 17, 2008
• First Submitted That Met QC Criteria: March 28, 2008
• First Posted (Estimate): March 31, 2008

Study Record Updates

• Last Update Posted (Estimate): July 12, 2010
• Last Update Submitted That Met QC Criteria: July 9, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Obstructive Sleep Apnea; Isoprostane; Alkane; Exhaled condensate; Peripheral arterial tonometry; Polysomnography; Hypoxia
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Hypoxia
• Other Study ID Numbers: P041012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No