Prevalence of Sleep Disordered Breathing

General Electric (GE)

Status: Terminated

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

Study type: Observational

Funder types: Industry

Identifiers

NCT01011647

2042500

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

53 participants in 1 patient group

Acute coronary conditions

Description:

Patients hospitalized with the following conditions * Unstable angina * Acute myocardial infarction * Congestive heart failure