Evaluating Accuracy of Breath Sound Recordings and STOP-Bang Screening For Obstructive Sleep Apnea While Awake

Completed

• Conditions: Sleep Apnea, Obstructive

• Registration Number: NCT02987283
• Lead Sponsor: Ottawa Hospital Research Institute

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2016-05-25
• Study Start: 2016-11
• Study First Submitted QC: 2016-12-06
• Study First Posted: 2016-12-08
• Primary Completion: 2018-09-20
• Study Completion: 2018-09-20
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-20
• Last Update Posted: 2020-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 439

Inclusion Criteria

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

Exclusion Criteria

• 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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Screening and diagnostic test performance of Awake-OSA and STOP-Bang	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.

Secondary Outcome Measures

Name	Time	Method
Development of new diagnostic algorithm determined by predictive values, sensibility, and specificity	Through study completion, average two years	The investigators will calculate positive and negative predictive values, sensibility, and specificity or each diagnostic tool tested in the study as well as for a combination of these tools to determine the best possible diagnostic algorithm for OSA. Positive and negative predictive values, sensibility, and specificity of the resulting diagnostic algorithm will be reported.

Trial Locations

Locations (1)

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada