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Clinical Trials/NCT01011647
NCT01011647
Terminated
Not Applicable

Prevalence of Sleep Disordered Breathing

GE Healthcare1 site in 1 country53 target enrollmentNovember 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Unstable Angina
Sponsor
GE Healthcare
Enrollment
53
Locations
1
Primary Endpoint
Sleep disordered breathing was detected either by signals obtained from patient monitoring or by standard approaches by the site.
Status
Terminated
Last Updated
14 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
November 2009
End Date
December 2011
Last Updated
14 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Sleep disordered breathing was detected either by signals obtained from patient monitoring or by standard approaches by the site.

Time Frame: 3 months

Secondary Outcomes

  • Length of CCU stay(3 months)
  • Length of hospital stay(3 months)
  • Prevalence of various sleep variables and correlation to known clinical and laboratory prognostic parameters(3 months)

Study Sites (1)

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