An interventional study of CPAP treatment in Sleep Apnea, sponsored by University Health Network, Toronto. Completed at 3 sites in Canada. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2022-11-02.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Prevention
Delirium is a common complication in elderly patients following surgery. Patients who develop delirium after surgery are at increased risk for serious complications, and even death.This multi-centre randomized controlled trial will enroll elderly patients scheduled for elective hip/knee replacement surgery.The objective of this trial is to identify obstructive sleep apnea using ApneaLink Air and to determine whether auto-titrating CPAP treatment of obstructive sleep apnea will decrease the incidence of post-operative delirium in elderly patients undergoing elective hip and knee replacement surgery.
Delirium is an acute and fluctuating change in cognitive function, characterized by poor attention and disorganized thinking. Recent studies show that patients with obstructive sleep apnea (OSA) - a sleep disorder characterized by repeated episodes of complete or partial blockage of the upper airway - are at greater risk to develop delirium. It is estimated that 43% of men and 27% of women aged 50-70 years old have OSA. Elderly individuals with this condition are often undiagnosed. Unrecognized OSA may be a treatable cause of postoperative delirium. However, timely access to polysomnography is usually not possible prior to surgery. This multi-centre randomized controlled trial will enroll elderly patients scheduled for elective hip/knee replacement surgery. All participants who have given the consent to participate will be assessed risks of OSA and comorbidity by 3 basic questionnaires- STOP-Bang, Epworth Sleepiness Scale and Charlson Comorbidity index, Cognitive level assess by Mini-Cog and baseline delirium assessment by CAM. STOP-Bang questionnaire is the validated questionnaire to screen the patients for OSA. Score of 3 or higher has sensitivity of detecting OSA of 93% and 100% for moderate and severe OSA respectively. If participant has STOP-Bang score 3 or higher will have a home sleep study with the ApneaLink Air and overnight oximetry. Patients identified to have OSA(AHI ≥10/h) will be randomized to 1) Auto-titrating continuous positive airway pressure (CPAP) applied 1-3 nights before surgery (if possible) and during day/night sleep for 72 hrs after surgery or 2) Control group - routine care. All patients will be evaluated for delirium for 72h after surgery.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 220 is above the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →University Health Network, Toronto is the lead sponsor of 1,411 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.
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Exclusion criteria
Auto-titrating Continuous Positive Airway Pressure (CPAP)) treatment will be given on postoperative days 1, 2, and 3.
Other: CPAP treatment
no auto-titrating CPAP, standard care
Patients who are randomized to auto-titrating CPAP will use an auto CPAP device on postoperative days 1, 2, and 3
postoperative delirium
The primary outcome is the incidence of postoperative delirium.
Time frame: 2 MONTHS
Length of Hospital Stay
This parameter depends on post operative recovery
Time frame: Depending on post operative recovery(2 days-2 months)
Time to ambulate
This parameter depending on lots of factors( eg; physiotherapy, weight, attitudes, other medical conditions ect...)
Time frame: 1 week to 2 months
Perioperative Complications
Post operative complications include ICU admissions, hypoxia, re-intubation, Myocardial Infarctions, Wound Infections, Deep Vein Thrombosis, Pneumonia, Sepsis, Urinary Tract Infection, Stroke, etc..)
Time frame: 10-14 days
Plan to share: No
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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University Health Network, Toronto