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

History of Changes

Tracking Information
First Received Date ^ICMJE	November 10, 2009
Last Updated Date	January 4, 2012
Start Date ^ICMJE	November 2009
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 10, 2009)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01011647 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 10, 2009)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Prevalence of Sleep Disordered Breathing
Official Title ^ICMJE	Prevalence of Sleep Disordered Breathing
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 Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Subject selection will come from patients admitted to the hospital with an acute cornonary condition.
Condition ^ICMJE	Unstable Angina Acute Myocardial Infarction Congestive Heart Failure
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Acute coronary conditions Patients hospitalized with the following conditions Unstable angina Acute myocardial infarction Congestive heart failure
Publications *	Guilleminault C, Tilkian A, Dement WC. The sleep apnea syndromes. Annu Rev Med. 1976;27:465-84. Review. No abstract available. 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. [No authors listed] 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. No abstract available. Eckert DJ, Jordan AS, Merchia P, Malhotra A. Central sleep apnea: Pathophysiology and treatment. Chest. 2007 Feb;131(2):595-607. Review. 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. Shamsuzzaman AS, Gersh BJ, Somers VK. Obstructive sleep apnea: implications for cardiac and vascular disease. JAMA. 2003 Oct 8;290(14):1906-14. Review. Peters RW. Obstructive sleep apnea and cardiovascular disease. Chest. 2005 Jan;127(1):1-3. No abstract available. 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. Epub 2008 Jan 31.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	53
Completion Date	December 2011
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01011647
Other Study ID Numbers ^ICMJE	2042500
Has Data Monitoring Committee	No
Responsible Party	GE Healthcare
Study Sponsor ^ICMJE	GE Healthcare
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	GE Healthcare
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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