Prevalence of Sleep Disordered Breathing

NCT ID: NCT01011647

Last Updated: 2012-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-12-31

Brief Summary

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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

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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.

Conditions

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Unstable Angina Acute Myocardial Infarction Congestive Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Acute coronary conditions

Patients hospitalized with the following conditions

* Unstable angina
* Acute myocardial infarction
* Congestive heart failure

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GE Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ohio State University Medical Center

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 180875 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 216912 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10450601 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17296668 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8464434 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14532320 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15653950 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18236092 (View on PubMed)

Other Identifiers

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2042500

Identifier Type: -

Identifier Source: org_study_id

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