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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2007 by Sociedad Española de Neumología y Cirugía Torácica. Recruitment status was Recruiting

First Received on April 2, 2007. No Changes Posted

Sponsor:	Sociedad Española de Neumología y Cirugía Torácica
Collaborators:	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:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Platelet Activation and Circadian Rhythms of Clotting-Fibrinolysis Factors in Patients With Sleep Apnea Syndrome. Implications in the Precipitation of Cardiovascular Events

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

Further study details as provided by Sociedad Española de Neumología y Cirugía Torácica:

Primary Outcome Measures:

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

Secondary Outcome Measures:

CPAP (Continuous Positive Airway Pressure) effect on studied variables

Estimated Enrollment:	40
Study Start Date:	February 2007

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.

Eligibility

Ages Eligible for Study:	25 Years to 65 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00456287

Contacts

Contact: Antonia Barceló, MD

34 971 175112

abarcelo@hsd.es

Locations

Spain
Hospital Universitario Son Dureta	Recruiting
Palma de Mallorca, Baleares, Spain, 07014

Sponsors and Collaborators

Sociedad Española de Neumología y Cirugía Torácica

Fondo de Investigacion Sanitaria

Fundacion Caubet-Cimera Islas Baleares

Investigators

Principal Investigator:

Antonia Barceló, MD

Hospital Universitario Son Dureta

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00456287 History of Changes
Other Study ID Numbers:	PR-109
Study First Received:	April 2, 2007
Last Updated:	April 2, 2007
Health Authority:	Spain: Ministry of Health and Consumption

Keywords provided by Sociedad Española de Neumología y Cirugía Torácica:

Sleep Apnea
Clotting- fibrinolysis patterns
Platelet function markers
Endothelial dysfunction

Additional relevant MeSH terms:

Apnea
Cardiovascular Diseases
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory

Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on February 09, 2012