Clinical trial NCT00487929: Oxidative Stress and Cardiovascular Morbidity in Sleep Apnea-Hypopnea Syndrome (SAHS)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sleep Apnea
Cardiovascular Diseases
Keywords: sleep apnea
morbidity
cardiovascular
cpap
oxidative stress
Lead sponsor: Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2007-06-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Plasmatic 8-isoprostane concentration
timeFrame: three months
Secondary outcomes:
measure: 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.
timeFrame: three months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: Servicio de Neumología. Hospital Universitario La Paz
name: Francisco García-Rio, PhD
role: STUDY_CHAIR
References: