Prevalence of Sleep Disordered Breathing

This study has been terminated.
(Inadequate recruitment)
Sponsor:
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01011647
First received: November 10, 2009
Last updated: January 4, 2012
Last verified: January 2012

November 10, 2009
January 4, 2012
November 2009
December 2011   (final data collection date for primary outcome measure)
Sleep disordered breathing was detected either by signals obtained from patient monitoring or by standard approaches by the site. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01011647 on ClinicalTrials.gov Archive Site
  • Length of CCU stay [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Prevalence of various sleep variables and correlation to known clinical and laboratory prognostic parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Prevalence of Sleep Disordered Breathing
Prevalence of Sleep Disordered Breathing

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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Subject selection will come from patients admitted to the hospital with an acute cornonary condition.

  • Unstable Angina
  • Acute Myocardial Infarction
  • Congestive Heart Failure
Not Provided
Acute coronary conditions

Patients hospitalized with the following conditions

  • Unstable angina
  • Acute myocardial infarction
  • Congestive heart failure

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
53
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01011647
2042500
No
GE Healthcare
GE Healthcare
Not Provided
Not Provided
GE Healthcare
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP