Screening Tools for Obstructive Sleep Apnea (OSA) in Hospitalized Medical Patients (STOMP)
18. juli 2013 opdateret af: Dennis Auckley, MD, MetroHealth Medical Center
Evaluation of Screening Tools for OSA in Hospitalized Medical Patients: A Validation Study
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.
Studieoversigt
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
110
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Ohio
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Cleveland, Ohio, Forenede Stater, 44109
- MetroHealth Medical Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Hospitalized medical patients
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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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. |
An attended polysomnogram will be conducted in the subjects room during an in patient hospital stay
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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.
Tidsramme: 1 year
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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.
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1 year
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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.
Tidsramme: 1 year
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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.
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1 year
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Dennis H Auckley, M.D., The MetroHealth System
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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. doi: 10.1097/ALN.0b013e31816d83e4.
- 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. doi: 10.1164/rccm.2109080.
- 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. doi: 10.7326/0003-4819-131-7-199910050-00002.
- 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. doi: 10.1097/00000542-198507000-00004.
- 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. doi: 10.1288/00005537-198911000-00004.
- 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. doi: 10.1016/j.sleep.2008.03.010. Epub 2008 Jul 9.
- 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.
- 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. doi: 10.4065/76.9.897.
- 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. doi: 10.1111/j.1399-6576.1995.tb04200.x.
- 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. doi: 10.1097/ALN.0b013e31816d91b5.
- 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. doi: 10.1016/j.cardfail.2009.05.005. Epub 2009 Jun 26.
- 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. doi: 10.1378/chest.130.3.780.
- 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. doi: 10.1378/chest.116.6.1558.
- 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. doi: 10.1007/BF02598994.
- 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. doi: 10.1093/sleep/27.8.1518.
- 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.
- Senthilvel E, Auckley D, Dasarathy J. Evaluation of sleep disorders in the primary care setting: history taking compared to questionnaires. J Clin Sleep Med. 2011 Feb 15;7(1):41-8.
- Auckley D, Ramsammy V, Shalhoub G, Khanna G. Suspected OSA in hospitalized patients: prevalence and potential for adverse events. Sleep 2010; 33:A136
- 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.
- 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. doi: 10.1164/ajrccm.150.5.7952553.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2012
Primær færdiggørelse (Faktiske)
1. februar 2013
Studieafslutning (Faktiske)
1. februar 2013
Datoer for studieregistrering
Først indsendt
21. april 2011
Først indsendt, der opfyldte QC-kriterier
21. april 2011
Først opslået (Skøn)
25. april 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
19. juli 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. juli 2013
Sidst verificeret
1. juli 2013
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Cephalon-01736
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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