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临床试验/NCT02987283
NCT02987283已完成不适用

Safer Sleep: A Diagnostic Accuracy Study Evaluating Breath Sound Recordings and STOP-Bang In Screening For Obstructive Sleep Apnea While Awake

Ottawa Hospital Research Institute1 个研究点 分布在 1 个国家目标入组 439 人开始时间: 2016年11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
439
试验地点
1
主要终点
Screening and diagnostic test performance of Awake-OSA and STOP-Bang

研究概览

简要总结

The investigators will perform a diagnostic accuracy study comparing tracheal breath sound recordings in awake individuals to the STOP-Bang screening questionnaire, using the apnea-hypopnea index (AHI) score determined by polysomnography as the gold standard.

详细描述

Obstructive sleep apnea (OSA) is a breathing disorder with numerous health effects including a greater risk of peri-operative anesthetic complications. Numerous screening tools exist but are not without limitations. Diagnostic overnight sleep studies are resource-intensive and difficult to obtain in the short time period between pre-operative clinic assessment and the day of surgery.

This project aims to test the diagnostic performance of a new screening technology, Awake-OSA, for screening of obstructive sleep apnea (OSA). "Awake-OSA" uses a small external microphone placed on the neck, to record and analyze tracheal breath sounds at the bedside while the patient is awake.

Using polysomnography (PSG) as a gold standard, the investigators will compare Awake-OSA (breath sound recording) and the STOP-Bang screening questionnaire in their ability to accurately identify patients with OSA, as well as classify OSA in terms of severity.

Early, point-of-care diagnosis has the potential to provide a low-cost, convenient alternative to traditional screening questionnaires and enable more selective use of PSG. Our goal is to improve peri-operative patient safety while improving use of resources and streamlining patient care.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years and older.
  • Referred for diagnostic sleep study.
  • Willing and able to consent.

排除标准

  • Under the age of 18 yrs.
  • Unwilling or unable to give consent.
  • Expected to have an abnormal EEG (epilepsy, brain tumour, deep brain stimulator).
  • Significant craniofacial abnormality (ex. unrepaired cleft lip/palate).

结局指标

主要结局

Screening and diagnostic test performance of Awake-OSA and STOP-Bang

时间窗: Night 1

Screening and diagnostic test performance of Awake-OSA and STOPBang in identifying OSA vs non-OSA patients, using AHI as gold-standard reference.

次要结局

  • Development of new diagnostic algorithm determined by predictive values, sensibility, and specificity(Through study completion, average two years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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