Prevalence of Sleep Disordered Breathing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01011647
Recruitment Status : Terminated (Inadequate recruitment)
First Posted : November 11, 2009
Last Update Posted : January 5, 2012
Information provided by (Responsible Party):
GE Healthcare

Brief Summary:
A novel technique in identifying unspecified sleep apnea has been developed. This technique uses signals typical acquired from a bedside monitor that is found in critical care environments. Those signals are then processed by a sleep analysis algorithm to provide an Apnoea Hypopnea Index (AHI) score. This study is intended to determine whether the prevalence of sleep disordered breathing identification among patients in a Coronary Care Unit (CCU) using this novel approach is significantly different than using routine techniques.

Condition or disease
Unstable Angina Acute Myocardial Infarction Congestive Heart Failure

Detailed Description:

This study will focus on inpatients diagnosed with coronary conditions. Specific eligibility criteria will include:

  • Unstable angina
  • Acute myocardial infarction
  • Congestive heart failure Subjects enrolled in the study will be scored for sleep apnea using a novel approach designed by the sponsor. That score will not be used in the course of treatment. A follow-up call will determine whether the subject was identified for sleep disordered breathing during the hospital stay. A comparison will be done on the number of those identified with and without the use of the sleep scoring device.

Study Type : Observational
Actual Enrollment : 53 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of Sleep Disordered Breathing
Study Start Date : November 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Acute coronary conditions

Patients hospitalized with the following conditions

  • Unstable angina
  • Acute myocardial infarction
  • Congestive heart failure

Primary Outcome Measures :
  1. Sleep disordered breathing was detected either by signals obtained from patient monitoring or by standard approaches by the site. [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Length of CCU stay [ Time Frame: 3 months ]
  2. Length of hospital stay [ Time Frame: 3 months ]
  3. Prevalence of various sleep variables and correlation to known clinical and laboratory prognostic parameters [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subject selection will come from patients admitted to the hospital with an acute cornonary condition.

Inclusion Criteria:

  • Age equal to or greater than 18 years at time of consent
  • Written informed consent
  • Patients admitted to the intensive care unit if able to remove oxygen
  • Patients admitted to telemetry and step-down floor that will not require oxygen
  • Primary diagnosis (any of the following)
  • Un-stable angina
  • Acute myocardial infarction
  • Congestive heart failure

Exclusion Criteria:

  • Previously diagnosed sleep disordered breathing
  • Inability to consent
  • Pregnancy
  • Intubation (no longer excluded after extubation)
  • Oxygen therapy (no longer excluded after therapy ends)
  • End-Stage renal disease
  • End-Stage liver disease
  • Terminal disorders other than cardiac
  • Severe scoliosis
  • Cervical spinal cord injuries
  • Neuromuscular disorders
  • Severe COPD as defined by prescription of home oxygen therapy
  • Other unsuitable circumstances

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 identifier (NCT number): NCT01011647

United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
GE Healthcare

Responsible Party: GE Healthcare Identifier: NCT01011647     History of Changes
Other Study ID Numbers: 2042500
First Posted: November 11, 2009    Key Record Dates
Last Update Posted: January 5, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Heart Failure
Myocardial Infarction
Angina, Unstable
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases
Angina Pectoris
Chest Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms