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

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ClinicalTrials.gov Identifier: NCT00456287
Recruitment Status : Unknown
Verified April 2007 by Sociedad Española de Neumología y Cirugía Torácica.
Recruitment status was:  Recruiting
First Posted : April 4, 2007
Last Update Posted : April 4, 2007
Sponsor:
Collaborators:
Fondo de Investigacion Sanitaria
Fundacion Caubet-Cimera Islas Baleares
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Sleep Apnea Cardiovascular Diseases Device: CPAP (Continuous Positive Airway Pressure) Not Applicable

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 Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea




Primary Outcome Measures :
  1. To define and compare clotting- fibrinolysis patterns, platelet function markers and endothelial dysfunction

Secondary Outcome Measures :
  1. CPAP (Continuous Positive Airway Pressure) effect on studied variables


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00456287     History of Changes
Other Study ID Numbers: PR-109
First Posted: April 4, 2007    Key Record Dates
Last Update Posted: April 4, 2007
Last Verified: April 2007

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 Wake Disorders
Nervous System Diseases