NCT02987283

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
439

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 8, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2018

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

1.9 years

First QC Date

May 25, 2016

Last Update Submit

March 20, 2020

Conditions

Sleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    Through study completion, average two years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Cohort will be selected from patients referred to the Ottawa Hospital sleep clinic for a diagnostic sleep study.

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, Canada

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Sylvain Boet, MD

    The Ottawa Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2016

First Posted

December 8, 2016

Study Start

November 1, 2016

Primary Completion

September 20, 2018

Study Completion

September 20, 2018

Last Updated

March 24, 2020

Record last verified: 2020-03

Locations

CA(1)