Pre-operative Polysomnography Assessment of Cardiac Surgery Inpatients

February 5, 2014 updated by: Cleveland Medical Devices Inc

Pre-operative PSG Assessment of Cardiac Surgery Inpatients

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

146

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

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

cardiac surgery patients

Description

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 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
Cardiac Surgeries: CABG, valve replacements

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of Sleep Disordered Breathing in Cardiac Surgery Patients
Time Frame: September 2009
September 2009

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess Post-Operative Complications of Patients with Sleep Disordered Breathing
Time Frame: September 2009
September 2009

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cleveland Medical Devices Inc

Collaborators

Johns Hopkins University
The Cleveland Clinic
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Hani A Kayyali, MS, Cleveland Medical Devices Inc
  • Principal Investigator: Nancy Foldvary, DO, The Cleveland Clinic
  • Principal Investigator: Nancy Collop, MD, Johns Hopkins University

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

March 1, 2007

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

June 15, 2009

First Submitted That Met QC Criteria

June 16, 2009

First Posted (Estimate)

June 17, 2009

Study Record Updates

Last Update Posted (Estimate)

February 6, 2014

Last Update Submitted That Met QC Criteria

February 5, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pre-op PSG
  • R44NS042451 (U.S. NIH Grant/Contract)

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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