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临床试验/NCT01340781
NCT01340781已完成不适用

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

MetroHealth Medical Center1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
1
主要终点
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.

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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.

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dennis Auckley, MD

Director, Center for Sleep Medicine

MetroHealth Medical Center

研究点 (1)

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