Skip to content

Prevalence of Sleep Disordered Breathing

Prevalence of Sleep Disordered Breathing

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01011647
Enrollment
53
Registered
2009-11-11
Start date
2009-11-30
Completion date
2011-12-31
Last updated
2012-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction, Congestive Heart Failure, Unstable Angina

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.

Interventions

None listed

Sponsors

GE Healthcare
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Length of CCU stay3 months
Length of hospital stay3 months
Prevalence of various sleep variables and correlation to known clinical and laboratory prognostic parameters3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026