Prevalence of Sleep Disordered Breathing

Terminated

• Conditions: Unstable Angina; Acute Myocardial Infarction; Congestive Heart Failure

• Registration Number: NCT01011647
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-10
• Study First Submitted QC: 2009-11-10
• Study First Posted: 2009-11-11
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-04
• Last Update Posted: 2012-01-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep disordered breathing was detected either by signals obtained from patient monitoring or by standard approaches by the site.	3 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States