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Pre-operative Polysomnography Assessment of Cardiac Surgery Inpatients

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ClinicalTrials.gov Identifier: NCT00922168
Recruitment Status : Completed
First Posted : June 17, 2009
Last Update Posted : February 6, 2014
Sponsor:
Collaborators:
National Institutes of Health (NIH)
The Cleveland Clinic
Johns Hopkins University
Information provided by (Responsible Party):
Cleveland Medical Devices Inc

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

Condition or disease
Sleep Disordered Breathing Obstructive Sleep Apnea Central Sleep Apnea

Study Type : Observational
Actual Enrollment : 146 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pre-operative PSG Assessment of Cardiac Surgery Inpatients
Study Start Date : March 2007
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Group/Cohort
Cardiac Surgeries: CABG, valve replacements



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

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


Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00922168


Locations
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
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

Additional Information:
Responsible Party: Cleveland Medical Devices Inc
ClinicalTrials.gov Identifier: NCT00922168     History of Changes
Other Study ID Numbers: Pre-op PSG
R44NS042451 ( U.S. NIH Grant/Contract )
First Posted: June 17, 2009    Key Record Dates
Last Update Posted: February 6, 2014
Last Verified: February 2014

Keywords provided by Cleveland Medical Devices Inc:
Sleep
apnea
obstructive
central

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Apnea, Central
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases