Oxidative Stress and Cardiovascular Morbidity in Sleep Apnea-Hypopnea Syndrome (SAHS)

Study Overview
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Brief Summary
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The purpose of this study is to compare the levels of 8-isoprostane and other oxidative stress biomarkers in plasma and condensed exhaled air between patients with SAHS and cardiovascular complications, patients with SAHS without cardiovascular complications and control subjects. To evaluate the effect of three months of treatment with CPAP on the oxidative stress biomarkers.

Detailed Description
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Aim: To compare the levels of 8-isoprostane and other oxidative stress biomarkers in plasma and condensed exhaled air between patients with SAHS and cardiovascular complications, patients with SAHS without cardiovascular complications and control subjects. To evaluate the effect of three months of treatment with CPAP on the oxidative stress biomarkers. Design: randomized, double blind, of parallel groups and controlled with placebo study. Study subjects: 53 patients with SAHS (23 with cardiovascular complications and 30 without cardiovascular complications), 23 patients with cardiovascular diseases without SAHS and 23 control subjects. Interventions: Three months of treatment with therapeutic CPAP or with sham CPAP (placebo). Determinations: clinical (cardiovascular morbidity) and anthropometric data. Fat free corporal mass, echocardiography, spirometry, ambulatory monitoring of the arterial pressure, endothelial reactivity. Oxidative stress biomarkers (8-isoprostane, homocysteine, HIF-1, NFkB, AP-1, VEGF, ET-1, TNF-alpha, IL-1, IL-6, ICAM-1, VCAM-1, nitrates and nitrites) in plasma and condensed exhaled air.Peripheral sensitivity to hypoxia. Urinary excretion of catecholamines.

Official Title
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Phase 4 Study of the Relationship Between the Oxidative Stress and the Development of Cardiovascular Complications in the Sleep Apnea-hypopnea Syndrome (SAHS). Effect of the Treatment With CPAP

Conditions
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Sleep Apnea, Cardiovascular Diseases

Intervention / Treatment
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* Device: nasal CPAP
* Device: Sham CPAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sleep apnea-hypopnea syndrome (AHI > 5) Excessive sleepiness (ESS > 11) No previous CPAP treatment Exclusion Criteria: Blood pressure > 180/120 mmHg. Secondary hypertension Professional driver COPD, asthma, bronchiectasis, lung cancer, restrictive lung disorder, chest wall disease Neuromuscular disease or thyroid function abnormalities Morbid obesity (BMI > 40 Kg/m2). Respiratory infection in the 2 last months. Anemia (Hb < 10 g/dl) or polyglobulia (Hct > 55%). Diurnal hypercapnia (PaCO2 > 45 mmHg) or moderate hypoxemia (PaO2 < 70 mmHg).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPAP<br>Continuous positive airway pressure | Device: nasal CPAP<br>* Nocturnal<br>|
| Sham Comparator: Sham CPAP<br>Sham nasal continuous positive airway pressure | Device: Sham CPAP<br>* Nocturnal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasmatic 8-isoprostane concentration |  | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasmatic and condensed exhaled air concentrations of homocysteine, HIF-1, NFkB, AP-1, VEGF, ET-1, TNF-alpha, IL-1, IL-6, ICAM-1, VCAM-1, nitrates and nitrites. |  | three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep apnea, morbidity, cardiovascular, cpap, oxidative stress