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NCT00922168 Clinical Trial

Pre-operative Polysomnography Assessment of Cardiac Surgery Inpatients

Obstructive Sleep Apnea Clinical Trial

Official title:
Pre-operative PSG Assessment of Cardiac Surgery Inpatients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00922168
Other study ID # Pre-op PSG
Secondary ID R44NS042451
Status Completed
Phase N/A
First received June 15, 2009
Last updated February 5, 2014
Start date March 2007
Est. completion date August 2010

Study information
Verified date February 2014
Source Cleveland Medical Devices Inc
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

The purpose of this study is to assess the prevalence and morbidity rates of sleep disordered breathing in cardiac surgery patients.

Recruitment information / eligibility
Status Completed
Enrollment 146
Est. completion date August 2010
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Subjects undergoing major cardiovascular surgery (coronary artery bypass graft, valve replacement surgery, or aortic surgery) under general anesthesia.

- Subjects in whom surgery is planned for greater than 1 day but less than 60 days from the time of enrollment.

Exclusion Criteria:

- Subjects treated for sleep apnea with positive airway pressure (PAP) therapy or oral appliance in the past 30 days.

- Subjects undergoing Maze procedure for atrial fibrillation.

- Subjects unable to comply with study procedures.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Johns Hopkins University Baltimore Maryland
United States Cleveland Clinic Foundation Cleveland Ohio

Sponsors (4)
Lead Sponsor Collaborator
Cleveland Medical Devices Inc Johns Hopkins University, National Institutes of Health (NIH), The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of Sleep Disordered Breathing in Cardiac Surgery Patients September 2009 No
Secondary Assess Post-Operative Complications of Patients with Sleep Disordered Breathing September 2009 Yes
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