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

Primary Purpose

Sleep Apnea, Cardiovascular Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
CPAP (Continuous Positive Airway Pressure)
Sponsored by
Sociedad Española de Neumología y Cirugía Torácica
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sleep Apnea focused on measuring Sleep Apnea, Clotting- fibrinolysis patterns, Platelet function markers, Endothelial dysfunction

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitario Son DuretaRecruiting

Outcomes

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

Full Information

First Posted
April 2, 2007
Last Updated
April 2, 2007
Sponsor
Sociedad Española de Neumología y Cirugía Torácica
Collaborators
Fondo de Investigacion Sanitaria, Fundacion Caubet-Cimera Islas Baleares
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1. Study Identification

Unique Protocol Identification Number
NCT00456287
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Unknown status
Study Start Date
February 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Sociedad Española de Neumología y Cirugía Torácica
Collaborators
Fondo de Investigacion Sanitaria, Fundacion Caubet-Cimera Islas Baleares

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Cardiovascular Diseases
Keywords
Sleep Apnea, Clotting- fibrinolysis patterns, Platelet function markers, Endothelial dysfunction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
CPAP (Continuous Positive Airway Pressure)
Primary Outcome Measure Information:
Title
To define and compare clotting- fibrinolysis patterns, platelet function markers and endothelial dysfunction
Secondary Outcome Measure Information:
Title
CPAP (Continuous Positive Airway Pressure) effect on studied variables

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonia Barceló, MD
Phone
34 971 175112
Email
abarcelo@hsd.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonia Barceló, MD
Organizational Affiliation
Hospital Universitario Son Dureta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Son Dureta
City
Palma de Mallorca
State/Province
Baleares
ZIP/Postal Code
07014
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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