- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01580085
Obstructive Sleep Apnea in Pulmonary Embolism
April 17, 2012 updated by: meral uyar, University of Gaziantep
Obstructive Sleep Apnea is Prevalent in Patients With Pulmonary Embolism
Obstructive sleep apnea (OSA) is a clinical syndrome characterized by repetitive closure of the airway and frequent awakenings during sleep.
Repeated episodes of hypoxia, decrease in intrathoracic pressure, increased venous return and venous stasis, damage to vascular wall may ensue.
An increased tendency for coagulation has also been reported in OSA.
Venous stasis, vascular endothelial activation and hypercoagulability are also known risk factors for thromboembolism.
All of these pathophysiologic changes in OSA may predispose patients for the development of pulmonary embolism (PE) however there is limited data about role of thromboembolic events in OSA.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
75
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Gaziantep, Turkey, 27310
- University of Gaziantep Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
All subjects admitted to Department of Pulmonary Medicine of Gaziantep University who were diagnosed to have PE were included in the study group.
Control group consisted of age and sex matched subjects without a clinic consistent with PE referred to the Sleep Clinic.
PE was diagnosed when one or more of the following was present: compatible physical examination findings and multislice CT angiography or presence of deep venous thrombus (DVT) in addition to high risk with Wells criteria [5].
Subjects with any restrictive/obstructive lung pathology or younger than 18 years old were excluded.
Description
Inclusion Criteria:
- All consecutive patients diagnosed with pulmonary embolism
Exclusion Criteria:
- less than 18 years of age
- any restrictive or obstructive lung disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Pulmonary embolism
Patients who were diagnosed with pulmonary embolism
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full night supervised laboratory polysomnography
Other Names:
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control group
age and sex matched adults with osa and no thromboembolism
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full night supervised laboratory polysomnography
Other Names:
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Meral Uyar, Assist Prof, University of Gaziantep
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
April 16, 2012
First Submitted That Met QC Criteria
April 17, 2012
First Posted (Estimate)
April 18, 2012
Study Record Updates
Last Update Posted (Estimate)
April 18, 2012
Last Update Submitted That Met QC Criteria
April 17, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Nervous System Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Lung Diseases
- Embolism and Thrombosis
- Signs and Symptoms, Respiratory
- Sleep Apnea Syndromes
- Sleep Apnea, Obstructive
- Embolism
- Apnea
- Thromboembolism
- Pulmonary Embolism
Other Study ID Numbers
- gantep gogus 1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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