NCT01580085

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 18, 2012

Completed
Last Updated

April 18, 2012

Status Verified

April 1, 2012

Enrollment Period

1.1 years

First QC Date

April 16, 2012

Last Update Submit

April 17, 2012

Conditions

Keywords

Sleep disordered breathinggenderhypercoagulability

Study Arms (2)

Pulmonary embolism

Patients who were diagnosed with pulmonary embolism

Other: polysomnography

control group

age and sex matched adults with osa and no thromboembolism

Other: polysomnography

Interventions

full night supervised laboratory polysomnography

Also known as: PSG
Pulmonary embolismcontrol group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • All consecutive patients diagnosed with pulmonary embolism

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Gaziantep Hospital

Gaziantep, 27310, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary EmbolismSleep Apnea, ObstructiveSleep Apnea SyndromesCoitusThrombophilia

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesApneaRespiration DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesSexual BehaviorBehaviorHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Meral Uyar, Assist Prof

    University of Gaziantep

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asisstant Professor

Study Record Dates

First Submitted

April 16, 2012

First Posted

April 18, 2012

Study Start

November 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

April 18, 2012

Record last verified: 2012-04

Locations