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Completed

NCT Number: NCT02987283

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ottawa Hospital

Ottawa, Ontario, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

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

    Time frame: 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 outcomes

  1. Development of new diagnostic algorithm determined by predictive values, sensibility, and specificity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Collaborators

  • The Ottawa Hospital Academic Medical Association

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 8, 2016
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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