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

Evaluation of Screening Tools for OSA in Hospitalized Medical Patients: A Validation Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01340781
Acronym
STOMP
Enrollment
110
Registered
2011-04-25
Start date
2012-02-29
Completion date
2013-02-28
Last updated
2013-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

inpatients, medical, polysomnogram, questionnaires

Brief summary

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: 1. 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. 2. 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.

Interventions

PROCEDUREPolysomnogram

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

Sponsors

Teva Pharmaceuticals USA
CollaboratorINDUSTRY
MetroHealth Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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.1 yearSubjects 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

MeasureTime frameDescription
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.1 yearSubjects 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026