Clinical trial NCT01340781: Screening Tools for Obstructive Sleep Apnea (OSA) in Hospitalized Medical Patients
Official title: Evaluation of Screening Tools for OSA in Hospitalized Medical Patients: A Validation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Keywords: inpatients
medical
polysomnogram
questionnaires
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
Collaborators: name: Teva Pharmaceuticals USA
First posted: 2011-04-25
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized medical patients

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.


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 1 year
Secondary outcomes:
measure: 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.
timeFrame: 1 year
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
Study officials:
affiliation: MetroHealth System, Ohio
name: Dennis H Auckley, M.D.
role: PRINCIPAL_INVESTIGATOR
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