Screening Tools for Obstructive Sleep Apnea (OSA) in Hospitalized Medical Patients (STOMP)
|ClinicalTrials.gov Identifier: NCT01340781|
Recruitment Status : Completed
First Posted : April 25, 2011
Last Update Posted : July 19, 2013
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 or disease||Intervention/treatment|
|Obstructive Sleep Apnea||Procedure: Polysomnogram|
|Study Type :||Observational|
|Actual Enrollment :||110 participants|
|Official Title:||Evaluation of Screening Tools for OSA in Hospitalized Medical Patients: A Validation Study|
|Study Start Date :||February 2012|
|Primary Completion Date :||February 2013|
|Study Completion Date :||February 2013|
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
- 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 ]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.
- 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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01340781
|United States, Ohio|
|MetroHealth Medical Center|
|Cleveland, Ohio, United States, 44109|
|Principal Investigator:||Dennis H Auckley, M.D.||The MetroHealth System|