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

NCT01340781 | Completed DMC

• 1 other identifier: Cephalon-01736
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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. 1.The prevalence of OSA in unselected hospitalized medical patients will be more than 50% of the study population.
2. 2.Screening tools will be able to accurately identify OSA in hospitalized medical patients.

Conditions

Obstructive Sleep Apnea

Keywords

inpatients; medical; polysomnogram; questionnaires

Outcome Measures

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.

  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 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.

  1 year

Study Arms (1)

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

Interventions

Polysomnogram PROCEDURE

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

Hospitalized medical patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized medical patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MetroHealth Medical Center: lead
• Teva Pharmaceuticals USA: collaborator

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Related Publications (23)

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  BACKGROUND

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MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Dennis H Auckley, M.D.

  MetroHealth System, Ohio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Sleep Medicine

Study Record Dates

• First Submitted: April 21, 2011
• First Posted: April 25, 2011
• Study Start: February 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: July 19, 2013

Record last verified: 2013-07

Locations

US (1)