Prevalence of Sleep Disordered Breathing

Acute Myocardial Infarction Clinical Trial

Official title:

Prevalence of Sleep Disordered Breathing

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01011647
• Other study ID #: 2042500
• Status: Terminated
• Phase: N/A
• First received: November 10, 2009
• Last updated: January 4, 2012
• Start date: November 2009
• Est. completion date: December 2011

Study information

• Verified date: January 2012
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 53
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Angina, Unstable
• Congestive Heart Failure
• Heart Failure
• Myocardial Infarction
• Unstable Angina

Locations

Country	Name	City	State
United States	Ohio State University Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

Eckert DJ, Jordan AS, Merchia P, Malhotra A. Central sleep apnea: Pathophysiology and treatment. Chest. 2007 Feb;131(2):595-607. Review. — View Citation

Guilleminault C, Tilkian A, Dement WC. The sleep apnea syndromes. Annu Rev Med. 1976;27:465-84. Review. — View Citation

Peters RW. Obstructive sleep apnea and cardiovascular disease. Chest. 2005 Jan;127(1):1-3. — View Citation

Shamsuzzaman AS, Gersh BJ, Somers VK. Obstructive sleep apnea: implications for cardiac and vascular disease. JAMA. 2003 Oct 8;290(14):1906-14. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep disordered breathing was detected either by signals obtained from patient monitoring or by standard approaches by the site.		3 months	No
Secondary	Length of CCU stay		3 months	No
Secondary	Length of hospital stay		3 months	No
Secondary	Prevalence of various sleep variables and correlation to known clinical and laboratory prognostic parameters		3 months	No