Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Pre-operative Polysomnography Assessment of Cardiac Surgery Inpatients

This study has been completed.
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 ] [ Designated as safety issue: No ]

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

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


Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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:
No publications provided

Responsible Party: Cleveland Medical Devices Inc Identifier: NCT00922168     History of Changes
Other Study ID Numbers: Pre-op PSG, R44NS42451
Study First Received: June 15, 2009
Last Updated: February 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Cleveland Medical Devices Inc:

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic processed this record on November 20, 2014