Screening Tools for Obstructive Sleep Apnea (OSA) in Hospitalized Medical Patients - Full Text View

Purpose

The prevalence of obstructive sleep apnea (OSA) in patients admitted to the hospital is likely significantly higher than the general population as hospitalized patients carry a high prevalence of co-morbid conditions, such as diabetes and cardiovascular diseases, that are commonly associated with OSA. The true prevalence of OSA in hospitalized patients is not known, though there is limited data suggesting that the rate of OSA in hospitalized patients is indeed high. Two studies have reported on the rate of polysomnographic (PSG) diagnosis of OSA in patients referred for OSA evaluation while in-hospital. These studies reported frequencies of 77% (in a retrospective study of 100 patients) and 88-100% (in an observational study of 250 patients). Similarly, 2 studies evaluated the prevalence of sleep disordered breathing in patients admitted with acutely decompensated heart failure, finding frequencies of sleep apnea in 97% (prospective study of 29 patients studied with PSG) and 75% (prospective study of 395 consecutive patients studied with portable monitors). However, all of these studies are limited by either study design (retrospective), small numbers, limited channel portable monitoring, or evaluations of highly select patient populations. Furthermore, none of these studies examined screening tools that may help to identify which patients are at risk for OSA and thus might require the more extensive and expensive objective testing.

This study will test the following hypotheses:

The prevalence of OSA in unselected hospitalized medical patients will be more than 50% of the study population.

Specific Aim 1: To determine the prevalence of OSA in a group of unselected hospitalized medical patients by a combination of sleep symptoms and PSG performed while in-hospital.
Screening tools will be able to accurately identify OSA in hospitalized medical patients.

Specific Aim 2: To determine the accuracy of different screening questionnaires for the diagnosis of OSA in hospitalized medical patients by comparing the questionnaire results to that of a PSG performed while in-hospital.

Condition	Intervention
Obstructive Sleep Apnea	Procedure: Polysomnogram

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Evaluation of Screening Tools for OSA in Hospitalized Medical Patients: A Validation Study

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

Further study details as provided by MetroHealth Medical Center:

Primary Outcome Measures:

To determine the prevalence of OSA in a group of unselected hospitalized medical patients by a combination of sleep symptoms and PSG performed while in-hospital. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Subjects will complete an overnight polysomnogram during an inpatient admission. Data from the PSG will be used to determine if the subject has sleep apnea.

Secondary Outcome Measures:

To determine the accuracy of different screening questionnaires for the diagnosis of OSA in hospitalized medical patients by comparing the questionnaire results to that of a PSG performed while in-hospital. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Subjects will complete 4 questionnaires (Berlin, STOP, STOP-BANG, SACS) used to assess risk for OSA prior to polysomnogram testing. The PSG data will be compared to the questionnaire results to determine the validity of the screening questionnaires.

Estimated Enrollment:	100
Study Start Date:	February 2012
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Hospitalized medical patients Adult age 18-65 years old admitted to the general medical floors at MetroHealth Medical Center who are expected to stay a minimum of 48 hours. Potential subjects cannot have a known diagnosis of OSA, a tracheostomy, respiratory failure requiring noninvasive ventilation, currently pre or post surgical intervention, or clinically unstable patients with plans for transfer to a higher acuity of care or transferred from intensive care.	Procedure: Polysomnogram An attended polysomnogram will be conducted in the subjects room during an in patient hospital stay

Groups/Cohorts

Assigned Interventions

Hospitalized medical patients

Adult age 18-65 years old admitted to the general medical floors at MetroHealth Medical Center who are expected to stay a minimum of 48 hours.

Potential subjects cannot have a known diagnosis of OSA, a tracheostomy, respiratory failure requiring noninvasive ventilation, currently pre or post surgical intervention, or clinically unstable patients with plans for transfer to a higher acuity of care or transferred from intensive care.

Procedure: Polysomnogram

An attended polysomnogram will be conducted in the subjects room during an in patient hospital stay

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Hospitalized medical patients

Criteria

Inclusion Criteria:

Adult age 18-65 years old
Admitted to the general medical floors at MetroHealth Medical Center
Expected stay of 48 hours
Competent to sign informed consent
Agreeable to participating in the study

Exclusion Criteria:

Known OSA
Patients with a tracheostomy
Clinically unstable patients with plans for transfer to a higher acuity of care
Patients with planned surgical interventions or status post operation during the admission
Patients transferred from intensive care
Patients with respiratory failure requiring noninvasive ventilation
Inability to comprehend or complete the questionnaires
Inability to tolerate a sleep study (i.e. allergic to testing components, refusal to wear leads)
Refusal to sign consent
Non-English speaking patients
In an isolation room

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01340781

Locations

United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109

Sponsors and Collaborators

MetroHealth Medical Center

Teva Pharmaceuticals USA

Investigators

Principal Investigator:

Dennis H Auckley, M.D.

The MetroHealth System

More Information

Publications:

Young T, Peppard PE, Gottlieb DJ. Epidemiology of obstructive sleep apnea: a population health perspective. Am J Respir Crit Care Med. 2002 May 1;165(9):1217-39. Review.

Hiestand DM, Britz P, Goldman M, Phillips B. Prevalence of symptoms and risk of sleep apnea in the US population: Results from the national sleep foundation sleep in America 2005 poll. Chest. 2006 Sep;130(3):780-6.

Goring K, Collop N. Sleep disordered breathing in hospitalized patients. J Clin Sleep Med. 2008 Apr 15;4(2):105-10.

Al-Jawder S, Bahammam A. Utility of daytime polysomnography for in-patients with suspected sleep-disordered breathing. Neurol Neurochir Pol. 2009 Mar-Apr;43(2):140-7.

Padeletti M, Green P, Mooney AM, Basner RC, Mancini DM. Sleep disordered breathing in patients with acutely decompensated heart failure. Sleep Med. 2009 Mar;10(3):353-60. Epub 2008 Jul 9.

Khayat RN, Jarjoura D, Patt B, Yamokoski T, Abraham WT. In-hospital testing for sleep-disordered breathing in hospitalized patients with decompensated heart failure: report of prevalence and patient characteristics. J Card Fail. 2009 Nov;15(9):739-46. Epub 2009 Jun 26.

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.

Namen AM, Wymer A, Case D, Haponik EF. Performance of sleep histories in an ambulatory medicine clinic: impact of simple chart reminders. Chest. 1999 Dec;116(6):1558-63.

Haponik EF, Frye AW, Richards B, Wymer A, Hinds A, Pearce K, McCall V, Konen J. Sleep history is neglected diagnostic information. Challenges for primary care physicians. J Gen Intern Med. 1996 Dec;11(12):759-61.

Reuveni H, Tarasiuk A, Wainstock T, Ziv A, Elhayany A, Tal A. Awareness level of obstructive sleep apnea syndrome during routine unstructured interviews of a standardized patient by primary care physicians. Sleep. 2004 Dec 15;27(8):1518-25.

Namen AM, Landry SH, Case LD, McCall WV, Dunagan DP, Haponik EF. Sleep histories are seldom documented on a general medical service. South Med J. 2001 Sep;94(9):874-9.

Gupta RM, Parvizi J, Hanssen AD, Gay PC. Postoperative complications in patients with obstructive sleep apnea syndrome undergoing hip or knee replacement: a case-control study. Mayo Clin Proc. 2001 Sep;76(9):897-905.

Mooe T, Gullsby S, Rabben T, Eriksson P. Sleep-disordered breathing: a novel predictor of atrial fibrillation after coronary artery bypass surgery. Coron Artery Dis. 1996 Jun;7(6):475-8.

Kaw R, Golish J, Ghamande S, Burgess R, Foldvary N, Walker E. Incremental risk of obstructive sleep apnea on cardiac surgical outcomes. J Cardiovasc Surg (Torino). 2006 Dec;47(6):683-9.

Esclamado RM, Glenn MG, McCulloch TM, Cummings CW. Perioperative complications and risk factors in the surgical treatment of obstructive sleep apnea syndrome. Laryngoscope. 1989 Nov;99(11):1125-9.

Catley DM, Thornton C, Jordan C, Lehane JR, Royston D, Jones JG. Pronounced, episodic oxygen desaturation in the postoperative period: its association with ventilatory pattern and analgesic regimen. Anesthesiology. 1985 Jul;63(1):20-8.

Sollevi A, Lindahl SG. Hypoxic and hypercapnic ventilatory responses during isoflurane sedation and anaesthesia in women. Acta Anaesthesiol Scand. 1995 Oct;39(7):931-8.

Netzer NC, Stoohs RA, Netzer CM, Clark K, Strohl KP. Using the Berlin Questionnaire to identify patients at risk for the sleep apnea syndrome. Ann Intern Med. 1999 Oct 5;131(7):485-91.

Chung F, Yegneswaran B, Liao P, Chung SA, Vairavanathan S, Islam S, Khajehdehi A, Shapiro CM. STOP questionnaire: a tool to screen patients for obstructive sleep apnea. Anesthesiology. 2008 May;108(5):812-21.

Chung F, Yegneswaran B, Liao P, Chung SA, Vairavanathan S, Islam S, Khajehdehi A, Shapiro CM. Validation of the Berlin questionnaire and American Society of Anesthesiologists checklist as screening tools for obstructive sleep apnea in surgical patients. Anesthesiology. 2008 May;108(5):822-30.

Flemons WW, Whitelaw WA, Brant R, Remmers JE. Likelihood ratios for a sleep apnea clinical prediction rule. Am J Respir Crit Care Med. 1994 Nov;150(5 Pt 1):1279-85.

Responsible Party:	Dennis Auckley, MD, Director, Center for Sleep Medicine, MetroHealth Medical Center
ClinicalTrials.gov Identifier:	NCT01340781 History of Changes
Other Study ID Numbers:	Cephalon-01736
Study First Received:	April 21, 2011
Last Updated:	November 19, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by MetroHealth Medical Center:

inpatients
medical
polysomnogram
questionnaires

Additional relevant MeSH terms:

Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory

Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on June 17, 2013

Screening Tools for Obstructive Sleep Apnea (OSA) in Hospitalized Medical Patients (STOMP)