A Phase 4 interventional study of nasal CPAP and Sham CPAP in Sleep Apnea and Cardiovascular Diseases, sponsored by Hospital Universitario La Paz. Completed at 1 site in Spain. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-04-02.
Sponsored by Hospital Universitario La Paz · Phase 4, Interventional, and Basic science
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.
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.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 100 is above the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →Hospital Universitario La Paz is the lead sponsor of 51 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Continuous positive airway pressure
Device: nasal CPAP
Sham nasal continuous positive airway pressure
Device: Sham CPAP
Nocturnal
Nocturnal
Plasmatic 8-isoprostane concentration
Time frame: three months
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.
Time frame: three months
This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.
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Hospital Universitario La Paz