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
  Purpose

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.


Condition
Unstable Angina
Acute Myocardial Infarction
Congestive Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of Sleep Disordered Breathing

Resource links provided by NLM:


Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 53
Study Start Date: November 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Acute coronary conditions

Patients hospitalized with the following conditions

  • Unstable angina
  • Acute myocardial infarction
  • Congestive heart failure

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  • Neuromuscular disorders
  • Severe COPD as defined by prescription of home oxygen therapy
  • Other unsuitable circumstances
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01011647

Locations
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
GE Healthcare
  More Information

Publications:
Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01011647     History of Changes
Other Study ID Numbers: 2042500
Study First Received: November 10, 2009
Last Updated: January 4, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Angina, Unstable
Heart Failure
Infarction
Myocardial Infarction
Sleep Apnea Syndromes
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Ischemia
Pathologic Processes
Necrosis
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on April 16, 2014