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NCT Number: NCT01340781

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

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polysomnogram

Procedure

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

Primary outcomes

  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.

    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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

MetroHealth Medical Center

Other

Collaborators

  • Teva Pharmaceuticals USA

Registry information

Official study title

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

Acronym: STOMP

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 25, 2011
Registry last updated
Jul 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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