Oxidative Stress and Endothelial Dysfunction in Obstructive Sleep Apnea

Oxidative Stress Clinical Trial

— SOREVAS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00646971
• Other study ID #: P041012
• Status: Terminated
• Phase: N/A
• First received: March 17, 2008
• Last updated: July 9, 2010
• Start date: January 2008
• Est. completion date: April 2010

Study information

• Verified date: May 2010
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Cardiovascular Risk
• Endothelial Dysfunction
• Intermittent Hypoxia
• Obstructive Sleep Apnea Syndrome
• Oxidative Stress
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• CPAP device
for 4 weeks
• Placebo device
for 4 weeks

Locations

Country	Name	City	State
France	Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère	Clamart

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To examine the effect of CPAP treatment on biochemical (markers of oxidative stress) abnormalities		1 and 4 weeks of treatment	No
Secondary	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	No
Secondary	To compare between patients and controls, the endothelium-dependent vascular relaxation		before and after nocturnal polysomnography	No
Secondary	To analyze the relationship between these biochemical and functional abnormalities and the standard criteria of severity of OSAS.		before and after nocturnal polysomnography	No
Secondary	To examine the effect of CPAP treatment on functional (endothelium-dependent vascular relaxation reactivity) abnormalities		1 and 4 weeks of treatment	No