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

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ClinicalTrials.gov Identifier: NCT00646971
Recruitment Status : Terminated (Insuffisent recrutment)
First Posted : March 31, 2008
Last Update Posted : July 12, 2010
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE March 17, 2008
First Posted Date  ICMJE March 31, 2008
Last Update Posted Date July 12, 2010
Study Start Date  ICMJE January 2008
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2008)
To examine the effect of CPAP treatment on biochemical (markers of oxidative stress) abnormalities [ Time Frame: 1 and 4 weeks of treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oxidative Stress and Endothelial Dysfunction in Obstructive Sleep Apnea
Official Title  ICMJE Exhaled Markers of Oxidative Stress and Endothelium-dependent Vascular Relaxation in Obstructive Sleep Apnea. Effect of Continuous Positive Airway Pressure Therapy.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Obstructive Sleep Apnea Syndrome
  • Endothelial Dysfunction
  • Oxidative Stress
  • Intermittent Hypoxia
  • Cardiovascular Risk
Intervention  ICMJE
  • Device: CPAP device
    for 4 weeks
    Other Name: CPAP
  • Device: Placebo device
    for 4 weeks
    Other Name: Placebo
Study Arms  ICMJE
  • Experimental: 1
    CPAP
    Intervention: Device: CPAP device
  • Sham Comparator: 2
    sham CPAP
    Intervention: Device: Placebo device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 9, 2010)
11
Original Estimated Enrollment  ICMJE
 (submitted: March 28, 2008)
65
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00646971
Other Study ID Numbers  ICMJE P041012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mathieu QUINTIN, Departement Clinical Research of Developpement
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP