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Pre-operative Polysomnography Assessment of Cardiac Surgery Inpatients

This study has been completed.
National Institutes of Health (NIH)
The Cleveland Clinic
Johns Hopkins University
Information provided by (Responsible Party):
Cleveland Medical Devices Inc Identifier:
First received: June 15, 2009
Last updated: February 5, 2014
Last verified: February 2014
The purpose of this study is to assess the prevalence and morbidity rates of sleep disordered breathing in cardiac surgery patients.

Sleep Disordered Breathing
Obstructive Sleep Apnea
Central Sleep Apnea

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pre-operative PSG Assessment of Cardiac Surgery Inpatients

Resource links provided by NLM:

Further study details as provided by Cleveland Medical Devices Inc:

Primary Outcome Measures:
  • Prevalence of Sleep Disordered Breathing in Cardiac Surgery Patients [ Time Frame: September 2009 ]

Secondary Outcome Measures:
  • Assess Post-Operative Complications of Patients with Sleep Disordered Breathing [ Time Frame: September 2009 ]

Enrollment: 146
Study Start Date: March 2007
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Cardiac Surgeries: CABG, valve replacements


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
cardiac surgery patients

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.
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Please refer to this study by its identifier: NCT00922168

United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Cleveland Medical Devices Inc
National Institutes of Health (NIH)
The Cleveland Clinic
Johns Hopkins University
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
  More Information

Additional Information:
Responsible Party: Cleveland Medical Devices Inc Identifier: NCT00922168     History of Changes
Other Study ID Numbers: Pre-op PSG
R44NS042451 ( US NIH Grant/Contract Award Number )
Study First Received: June 15, 2009
Last Updated: February 5, 2014

Keywords provided by Cleveland Medical Devices Inc:

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Apnea, Central
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases processed this record on April 26, 2017