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

Not Applicable

• Conditions: Sleep Apnea; Cardiovascular Diseases

• Registration Number: NCT00456287
• Lead Sponsor: Sociedad Española de Neumología y Cirugía Torácica

Brief 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.

Study Timeline

• Study Start: 2007-02
• Status Verified: 2007-04
• Study First Submitted: 2007-04-02
• Study First Submitted QC: 2007-04-02
• Last Update Submitted: 2007-04-02
• Study First Posted: 2007-04-04
• Last Update Posted: 2007-04-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• Apnea-Hypopnea Index > 15

Exclusion Criteria

• Presence of any chronic disease
• Presence of cardiovascular disease
• Refusal to sign informed consent
• Drug addiction and/or alcoholism
• Any medication two weeks before

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To define and compare clotting- fibrinolysis patterns, platelet function markers and endothelial dysfunction

Secondary Outcome Measures

Name	Time	Method
CPAP (Continuous Positive Airway Pressure) effect on studied variables

Trial Locations

Locations (1)

Hospital Universitario Son Dureta; 🇪🇸 Palma de Mallorca, Baleares, Spain