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

July 18, 2013 updated by: 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:

  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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospitalized medical patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MetroHealth Medical Center

Collaborators

Teva Pharmaceuticals USA

Investigators

  • Principal Investigator: Dennis H Auckley, M.D., The MetroHealth System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

April 21, 2011

First Submitted That Met QC Criteria

April 21, 2011

First Posted (Estimate)

April 25, 2011

Study Record Updates

Last Update Posted (Estimate)

July 19, 2013

Last Update Submitted That Met QC Criteria

July 18, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cephalon-01736

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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