An observational study in Obstructive Sleep Apnea, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-11.
Sponsored by University Health Network, Toronto · Observational
Current practice guidelines recommend obstructive sleep apnea (OSA) patients to stay in the post anesthetic care unit (PACU) until the risk of respiratory depression has subsided. Inevitably, a greater demand on hospital resource utilization in these patients will increase health care cost. Polysomnography (PSG) and screening questionnaires can identify OSA but they are limited by accessibility and false positive results, respectively. Inaccurate OSA identification misguides postoperative surveillance plan. In contrast with MRI and CT scans, ultrasound is more accessible and more likely a practical tool for OSA screening. However, before clinical application, airway ultrasound (US) exam must undergo vigorous testing to check its utility, accuracy, inter-observer reliability and its ability to identify OSA and its severity.
The investigators plan to recruit surgical patients at risk of OSA, exposed to sedatives,and/or general anesthesia. Surface ultrasound measurements will be conducted in a separate setting, and be correlated with the sleep study results, and a set of ultrasound parameters will be validated in this setting. Relevant clinical outcomes will be captured as well.
2,263 studies on the registry are indexed under Sleep Apnea, Obstructive; 465 are open to participants now.
This study's enrollment of 200 is above the median of 105 across 666 observational studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →University Health Network, Toronto is the lead sponsor of 1,432 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Suspected / Recently diagnosed untreated Obstructive Sleep Apnea (amendment authorized 20/12/2017) / Non-compliant to OSA treatment
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria
Correlation of airway parameter measurements with Apnea-Hypopnea Index (AHI) values on Polysomnography (PSG)
The primary study outcome will be the discriminatory performance of each one of the airway parameters, against the OSA status (moderate/severe) as diagnosed by PSG.
Time frame: 2 years
Feasibility of airway Ultrasound (US) examination;
1. The feasibility and efficiency of completing the US exam and reading the measurements; 2. The inter-rater reliability for measuring each one of the airway parameters; 3. The statistical association between each airway parameter and OSA severity level (none/mild/moderate/severe); 4. The diagnostic accuracy for STOPBang (SB) score (ROC curve, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio, negative likelihood ratios, and diagnostic odds ratio (DOR) for different cut off levels); 5. The correlation between each one of the airway parameters and the SB score; and 6. The benefit of considering airway parameters in addition to SB in a prediction model for OSA.
Time frame: 2 years
Ran from Jul 2017 to primary completion in Jun 2022, 59 months.
Of 259 non-industry observational studies under Sleep Apnea, Obstructive, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 60. This study's 59 months is above that.
Counting every sponsor, half of 294 studies reached it within 30 months; a quarter within 15 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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University Health Network, Toronto →