Prevalence of Sleep Disordered Breathing

• Sponsor: GE Healthcare (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01011647
• Collaborator: (none)
• Enrollment: 53
• Location: 1
• Duration (Months): 25
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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.

Study Design

• Study Type: Observational
• Actual Enrollment: 53 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prevalence of Sleep Disordered Breathing
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Acute coronary conditions Patients hospitalized with the following conditions Unstable angina Acute myocardial infarction Congestive heart failure

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Length of CCU stay [3 months]

2. Length of hospital stay [3 months]

3. Prevalence of various sleep variables and correlation to known clinical and laboratory prognostic parameters [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ohio State University Medical Center	Columbus	Ohio	United States	43210

Sponsors and Collaborators

• GE Healthcare

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Block AJ, Boysen PG, Wynne JW, Hunt LA. Sleep apnea, hypopnea and oxygen desaturation in normal subjects. A strong male predominance. N Engl J Med. 1979 Mar 8;300(10):513-7.
• Eckert DJ, Jordan AS, Merchia P, Malhotra A. Central sleep apnea: Pathophysiology and treatment. Chest. 2007 Feb;131(2):595-607. Review.
• Guilleminault C, Tilkian A, Dement WC. The sleep apnea syndromes. Annu Rev Med. 1976;27:465-84. Review.
• Peters RW. Obstructive sleep apnea and cardiovascular disease. Chest. 2005 Jan;127(1):1-3.
• Shamsuzzaman AS, Gersh BJ, Somers VK. Obstructive sleep apnea: implications for cardiac and vascular disease. JAMA. 2003 Oct 8;290(14):1906-14. Review.
• Sleep-related breathing disorders in adults: recommendations for syndrome definition and measurement techniques in clinical research. The Report of an American Academy of Sleep Medicine Task Force. Sleep. 1999 Aug 1;22(5):667-89. Review.
• Spurr KF, Graven MA, Gilbert RW. Prevalence of unspecified sleep apnea and the use of continuous positive airway pressure in hospitalized patients, 2004 National Hospital Discharge Survey. Sleep Breath. 2008 Aug;12(3):229-34. doi: 10.1007/s11325-007-0166-2. Epub 2008 Jan 31.
• Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5.

• Responsible Party: GE Healthcare
• ClinicalTrials.gov Identifier: NCT01011647
• Other Study ID Numbers: 2042500
• First Posted: Nov 11, 2009
• Last Update Posted: Jan 5, 2012
• Last Verified: Jan 1, 2012

• Additional relevant MeSH terms: Sleep Apnea Syndromes; Heart Failure; Myocardial Infarction; Angina, Unstable; Infarction

Study Results

No Results Posted as of Jan 5, 2012