Obstructive Sleep Apnea in Pulmonary Embolism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
meral uyar, University of Gaziantep
ClinicalTrials.gov Identifier:
NCT01580085
First received: April 16, 2012
Last updated: April 17, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Pulmonary Thromboembolism
Obstructive Sleep Apnea
Other: polysomnography

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Obstructive Sleep Apnea is Prevalent in Patients With Pulmonary Embolism

Resource links provided by NLM:


Further study details as provided by University of Gaziantep:

Enrollment: 75
Study Start Date: November 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pulmonary embolism
Patients who were diagnosed with pulmonary embolism
Other: polysomnography
full night supervised laboratory polysomnography
Other Name: PSG
control group
age and sex matched adults with osa and no thromboembolism
Other: polysomnography
full night supervised laboratory polysomnography
Other Name: PSG

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • All consecutive patients diagnosed with pulmonary embolism

Exclusion Criteria:

  • less than 18 years of age
  • any restrictive or obstructive lung disease
  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: NCT01580085

Locations
Turkey
University of Gaziantep Hospital
Gaziantep, Turkey, 27310
Sponsors and Collaborators
University of Gaziantep
Investigators
Principal Investigator: Meral Uyar, Assist Prof University of Gaziantep
  More Information

No publications provided

Responsible Party: meral uyar, Asisstant Professor, University of Gaziantep
ClinicalTrials.gov Identifier: NCT01580085     History of Changes
Other Study ID Numbers: gantep gogus 1
Study First Received: April 16, 2012
Last Updated: April 17, 2012
Health Authority: Turkey: Ministry of Health

Keywords provided by University of Gaziantep:
Sleep disordered breathing
gender
hypercoagulability

Additional relevant MeSH terms:
Apnea
Embolism
Pulmonary Embolism
Sleep Apnea Syndromes
Thromboembolism
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Thrombosis

ClinicalTrials.gov processed this record on August 27, 2014