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Insuffisent recrutment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | CPAP |
|
| 2 | Sham Comparator | sham CPAP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP device | Device | for 4 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| To examine the effect of CPAP treatment on biochemical (markers of oxidative stress) abnormalities | 1 and 4 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| To compare between patients and controls, the endothelium-dependent vascular relaxation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre ESCOURROU, MD, PhD | Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère | Study Director |
| Gabriel ROISMAN, MD, PhD | Assistance Publique - Hôpitaux de Paris, Hôpital Antoine Béclère | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère | Clamart | 92141 | France |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Placebo device |
| Device |
for 4 weeks |
|
|
| before and after nocturnal polysomnography |
| To analyze the relationship between these biochemical and functional abnormalities and the standard criteria of severity of OSAS. | before and after nocturnal polysomnography |
| To examine the effect of CPAP treatment on functional (endothelium-dependent vascular relaxation reactivity) abnormalities | 1 and 4 weeks of treatment |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |