Oxidative Stress and Cardiovascular Morbidity in Sleep Apnea-Hypopnea Syndrome (SAHS) (OSCAMSA)
|ClinicalTrials.gov Identifier: NCT00487929|
Recruitment Status : Completed
First Posted : June 19, 2007
Last Update Posted : April 2, 2013
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea Cardiovascular Diseases||Device: nasal CPAP Device: Sham CPAP||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|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 Start Date :||June 2007|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||October 2012|
Continuous positive airway pressure
Device: nasal CPAP
Sham Comparator: Sham CPAP
Sham nasal continuous positive airway pressure
Device: Sham CPAP
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00487929
|Hospital Universitario La Paz|
|Madrid, Spain, 28046|
|Study Chair:||Francisco García-Rio, PhD||Servicio de Neumología. Hospital Universitario La Paz|