Prevalence of Sleep Disordered Breathing

NCT01011647 | Terminated

• 1 other identifier: 2042500
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Unstable Angina; Acute Myocardial Infarction; Congestive Heart Failure

Outcome Measures

Primary Outcomes (1)

• Sleep disordered breathing was detected either by signals obtained from patient monitoring or by standard approaches by the site.

  3 months

Secondary Outcomes (3)

• Length of CCU stay

  3 months

• Length of hospital stay

  3 months

• Prevalence of various sleep variables and correlation to known clinical and laboratory prognostic parameters

  3 months

Study Arms (1)

Acute coronary conditions

Patients hospitalized with the following conditions * Unstable angina * Acute myocardial infarction * Congestive heart failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Publications (8)

• Guilleminault C, Tilkian A, Dement WC. The sleep apnea syndromes. Annu Rev Med. 1976;27:465-84. doi: 10.1146/annurev.me.27.020176.002341. No abstract available.

  PMID: 180875 BACKGROUND

• 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. doi: 10.1056/NEJM197903083001001.

  PMID: 216912 BACKGROUND

• 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. No abstract available.

  PMID: 10450601 BACKGROUND

• Eckert DJ, Jordan AS, Merchia P, Malhotra A. Central sleep apnea: Pathophysiology and treatment. Chest. 2007 Feb;131(2):595-607. doi: 10.1378/chest.06.2287.

  PMID: 17296668 BACKGROUND

• 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. doi: 10.1056/NEJM199304293281704.

  PMID: 8464434 BACKGROUND

• Shamsuzzaman AS, Gersh BJ, Somers VK. Obstructive sleep apnea: implications for cardiac and vascular disease. JAMA. 2003 Oct 8;290(14):1906-14. doi: 10.1001/jama.290.14.1906.

  PMID: 14532320 BACKGROUND

• Peters RW. Obstructive sleep apnea and cardiovascular disease. Chest. 2005 Jan;127(1):1-3. doi: 10.1378/chest.127.1.1. No abstract available.

  PMID: 15653950 BACKGROUND

• 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.

  PMID: 18236092 BACKGROUND

MeSH Terms

Conditions

Angina, Unstable; Heart Failure

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2009
• First Posted: November 11, 2009
• Study Start: November 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 5, 2012

Record last verified: 2012-01

Locations

US (1)