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

This study has been terminated.
(Insuffisent recrutment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00646971
First Posted: March 31, 2008
Last Update Posted: July 12, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Assistance Publique - Hôpitaux de Paris
  Purpose
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.

Condition Intervention
Obstructive Sleep Apnea Syndrome Endothelial Dysfunction Oxidative Stress Intermittent Hypoxia Cardiovascular Risk Device: CPAP device Device: Placebo device

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Exhaled Markers of Oxidative Stress and Endothelium-dependent Vascular Relaxation in Obstructive Sleep Apnea. Effect of Continuous Positive Airway Pressure Therapy.

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • To examine the effect of CPAP treatment on biochemical (markers of oxidative stress) abnormalities [ Time Frame: 1 and 4 weeks of treatment ]

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

Enrollment: 11
Study Start Date: January 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
CPAP
Device: CPAP device
for 4 weeks
Other Name: CPAP
Sham Comparator: 2
sham CPAP
Device: Placebo device
for 4 weeks
Other Name: Placebo

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.
  Eligibility

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00646971


Locations
France
Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère
Clamart, France, 92141
Sponsors and Collaborators
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 - Hôpitaux de Paris, Hôpital Antoine Béclère
  More Information

Responsible Party: Mathieu QUINTIN, Departement Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT00646971     History of Changes
Other Study ID Numbers: P041012
First Submitted: March 17, 2008
First Posted: March 31, 2008
Last Update Posted: July 12, 2010
Last Verified: May 2010

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Isoprostane
Alkane
Exhaled condensate
Peripheral arterial tonometry
Polysomnography
Obstructive Sleep Apnea
Hypoxia

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Hypoxia
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases