Clinical Trials Directory

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UnknownNCT00456287

Platelet Activation and Circadian Rhythms of Clotting-Fibrinolysis Factors in Patients With Sleep Apnea Syndrome

Platelet Activation and Circadian Rhythms of Clotting-Fibrinolysis Factors in Patients With Sleep Apnea Syndrome. Implications in the Precipitation of Cardiovascular Events

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
40 (planned)
Sponsor
Sociedad Española de Neumología y Cirugía Torácica · Academic / Other
Sex
Male
Age
25 Years – 65 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DEVICECPAP (Continuous Positive Airway Pressure)

Timeline

Start date
2007-02-01
First posted
2007-04-04
Last updated
2007-04-04

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT00456287. Inclusion in this directory is not an endorsement.