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| Sponsors and Collaborators: |
Sociedad Española de Neumología y Cirugía Torácica Fondo de Investigacion Sanitaria Fundacion Caubet-Cimera Islas Baleares |
|---|---|
| Information provided by: | Sociedad Española de Neumología y Cirugía Torácica |
| ClinicalTrials.gov Identifier: | NCT00456287 |
Purpose
The objective of the study is to define and compare clotting- fibrinolysis patterns, platelet function markers and endothelial dysfunction in patients with SAHS before and after treatment and normal controls age and weight matched.
| Condition | Intervention |
|---|---|
|
Sleep Apnea Cardiovascular Diseases |
Device: CPAP (Continuous Positive Airway Pressure) |
| Study Type: | Interventional |
| Study Design: | Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Platelet Activation and Circadian Rhythms of Clotting-Fibrinolysis Factors in Patients With Sleep Apnea Syndrome. Implications in the Precipitation of Cardiovascular Events |
| Estimated Enrollment: | 40 |
| Study Start Date: | February 2007 |
The hypothesis of the study is the following: Patients with sleep apnea-hypopnea syndrome have higher risk of cardiovascular mortality during the night. Respiratory alterations (hypoxia, hypoxia- reoxygenation) that these patients suffer during the sleep may induce modifications in platelet function, clotting-fibrinolysis factors and endothelial function, that may accelerate cardiovascular events during the night
DESIGN: Prospective and controlled study
METHODS: 20 SAHS patients and 20 controls will be studied. The study includes:
a) medical history; b) anthropometric variables (weight, height, body mass index, waist-hip ratio); c) sleepiness tested by Epworth scale; d) conventional polysomnography (PSG); e) testing every 4 hours for a 24 hours period: clotting-fibrinolysis factors (factor V, VII, VIII; C and S protein, plasminogen tissular activator (t-PA) and inhibitor of plasminogen activator (PAI-1); platelet activation markers (CD62, CD63 and GPIIb/IIIa) and endothelial dysfunction markers (endothelins, nitrites/nitrates and asymmetrical dimethyl-arginine); f) basic biochemical profile and hemogram. Patients will be revaluated after 6 months of CPAP treatment.
Eligibility| Ages Eligible for Study: | 25 Years to 65 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Antonia Barceló, MD | 34 971 175112 | abarcelo@hsd.es |
| Spain, Baleares | |
| Hospital Universitario Son Dureta | Recruiting |
| Palma de Mallorca, Baleares, Spain, 07014 | |
| Principal Investigator: | Antonia Barceló, MD | Hospital Universitario Son Dureta |
More Information
| Study ID Numbers: | PR-109 |
| Study First Received: | April 2, 2007 |
| Last Updated: | April 2, 2007 |
| ClinicalTrials.gov Identifier: | NCT00456287 History of Changes |
| Health Authority: | Spain: Ministry of Health and Consumption |
|
Sleep Apnea Clotting- fibrinolysis patterns Platelet function markers Endothelial dysfunction |
|
Signs and Symptoms Sleep Apnea Syndromes Respiratory Tract Diseases Apnea Respiration Disorders |
Dyssomnias Sleep Disorders Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic |
|
Signs and Symptoms Sleep Apnea Syndromes Respiratory Tract Diseases Apnea Nervous System Diseases Respiration Disorders |
Sleep Disorders Dyssomnias Signs and Symptoms, Respiratory Cardiovascular Diseases Sleep Disorders, Intrinsic |
