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
Sponsor:
Collaborators:
Fondo de Investigacion Sanitaria
Fundacion Caubet-Cimera Islas Baleares
Information provided by:
Sociedad Española de Neumología y Cirugía Torácica
ClinicalTrials.gov Identifier:
NCT00456287
First received: April 2, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on October 23, 2014