search
Back to results

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

Primary Purpose

Obstructive Sleep Apnea Syndrome, Endothelial Dysfunction, Oxidative Stress

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CPAP device
Placebo device
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea Syndrome focused on measuring Isoprostane, Alkane, Exhaled condensate, Peripheral arterial tonometry, Polysomnography, Obstructive Sleep Apnea, Hypoxia

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

1

2

Arm Description

CPAP

sham CPAP

Outcomes

Primary Outcome Measures

To examine the effect of CPAP treatment on biochemical (markers of oxidative stress) abnormalities

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
To compare between patients and controls, the endothelium-dependent vascular relaxation
To analyze the relationship between these biochemical and functional abnormalities and the standard criteria of severity of OSAS.
To examine the effect of CPAP treatment on functional (endothelium-dependent vascular relaxation reactivity) abnormalities

Full Information

First Posted
March 17, 2008
Last Updated
July 9, 2010
Sponsor
Assistance Publique - Hôpitaux de Paris
search

1. Study Identification

Unique Protocol Identification Number
NCT00646971
Brief Title
Oxidative Stress and Endothelial Dysfunction in Obstructive Sleep Apnea
Acronym
SOREVAS
Official Title
Exhaled Markers of Oxidative Stress and Endothelium-dependent Vascular Relaxation in Obstructive Sleep Apnea. Effect of Continuous Positive Airway Pressure Therapy.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Terminated
Why Stopped
Insuffisent recrutment
Study Start Date
January 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome, Endothelial Dysfunction, Oxidative Stress, Intermittent Hypoxia, Cardiovascular Risk
Keywords
Isoprostane, Alkane, Exhaled condensate, Peripheral arterial tonometry, Polysomnography, Obstructive Sleep Apnea, Hypoxia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
CPAP
Arm Title
2
Arm Type
Sham Comparator
Arm Description
sham CPAP
Intervention Type
Device
Intervention Name(s)
CPAP device
Other Intervention Name(s)
CPAP
Intervention Description
for 4 weeks
Intervention Type
Device
Intervention Name(s)
Placebo device
Other Intervention Name(s)
Placebo
Intervention Description
for 4 weeks
Primary Outcome Measure Information:
Title
To examine the effect of CPAP treatment on biochemical (markers of oxidative stress) abnormalities
Time Frame
1 and 4 weeks of treatment
Secondary Outcome Measure Information:
Title
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
Title
To compare between patients and controls, the endothelium-dependent vascular relaxation
Time Frame
before and after nocturnal polysomnography
Title
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
Title
To examine the effect of CPAP treatment on functional (endothelium-dependent vascular relaxation reactivity) abnormalities
Time Frame
1 and 4 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre ESCOURROU, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gabriel ROISMAN, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris, Hôpital Antoine Béclère
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère
City
Clamart
ZIP/Postal Code
92141
Country
France

12. IPD Sharing Statement

Learn more about this trial

Oxidative Stress and Endothelial Dysfunction in Obstructive Sleep Apnea

We'll reach out to this number within 24 hrs