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

This study has been terminated.
(Insuffisent recrutment)
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00646971
First received: March 17, 2008
Last updated: July 9, 2010
Last verified: May 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • To compare between patients and controls, the endothelium-dependent vascular relaxation [ Time Frame: before and after nocturnal polysomnography ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To examine the effect of CPAP treatment on functional (endothelium-dependent vascular relaxation reactivity) abnormalities [ Time Frame: 1 and 4 weeks of treatment ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Mathieu QUINTIN, Departement Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT00646971     History of Changes
Other Study ID Numbers: P041012
Study First Received: March 17, 2008
Last Updated: July 9, 2010
Health Authority: France: Ministry of Health

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
Anoxia
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on July 23, 2014