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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

April 2, 2007

Last Updated Date

April 2, 2007

Start Date ^†

February 2007

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^†

CPAP (Continuous Positive Airway Pressure) effect on studied variables

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

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 Phase

Study Type ^†

Interventional

Study Design ^†

Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Sleep Apnea
Cardiovascular Diseases

Intervention ^†

Device: CPAP (Continuous Positive Airway Pressure)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility Criteria ^†

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

Gender

Male

Ages

25 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Antonia Barceló, MD

34 971 175112

abarcelo@hsd.es

Location Countries ^†

Spain

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00456287

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Sociedad Española de Neumología y Cirugía Torácica

Collaborators ^††

Fondo de Investigacion Sanitaria
Fundacion Caubet-Cimera Islas Baleares

Investigators ^†

Principal Investigator:

Antonia Barceló, MD

Hospital Universitario Son Dureta

Information Provided By

Sociedad Española de Neumología y Cirugía Torácica

Verification Date

April 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.