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

Sleep Apnea, Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02987283
• Other study ID #: REB 2016-0494
• Status: Completed
• Start date: November 2016
• Est. completion date: September 20, 2018

Study information

• Verified date: March 2020
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 439
• Est. completion date: September 20, 2018
• Est. primary completion date: September 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	The Ottawa Hospital Academic Medical Association

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Screening and diagnostic test performance of Awake-OSA and STOP-Bang	Screening and diagnostic test performance of Awake-OSA and STOPBang in identifying OSA vs non-OSA patients, using AHI as gold-standard reference.	Night 1
Secondary	Development of new diagnostic algorithm determined by predictive values, sensibility, and specificity	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.	Through study completion, average two years