Actively Recruiting
Screening Using Portable Electronic Recorders for Sleep Apnea in Hypertensive At-Risk Populations (SUPER-SHARP Trial)
Led by Sunnybrook Health Sciences Centre · Updated on 2025-02-11
190
Participants Needed
3
Research Sites
21 weeks
Total Duration
On this page
Sponsors
S
Sunnybrook Health Sciences Centre
Lead Sponsor
W
Women's College Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to compare two methods of diagnosing obstructive sleep apnea (OSA) in adults with hypertension who are at high risk for OSA. OSA is linked to increased risks of heart disease, stroke, and death, and treating it with continuous positive airway pressure (CPAP) can lower blood pressure. The study evaluates whether home sleep apnea testing leads to higher diagnosis and treatment rates, better blood pressure control, improved sleep quality, and greater patient satisfaction compared to the standard in-laboratory polysomnography. The study also looks at whether home testing is cost-effective. Participants will be randomly assigned to one of two groups. One group will use a home sleep apnea test device that measures breathing effort, pulse, oxygen levels, and airflow to detect OSA. The other group will receive the standard in-laboratory polysomnography test. Both methods are devices designed to identify sleep apnea, but home testing may offer more convenience and accessibility. The study lasts 6 months, during which diagnosis and treatment will be assessed. During the study, participants will be monitored for OSA diagnosis, use of CPAP treatment, changes in 24-hour ambulatory blood pressure, sleep-related quality of life, daytime sleepiness, and satisfaction with sleep testing. These outcomes will be measured at 6 months to determine the impact of each testing method. The study is sponsored by Sunnybrook Health Sciences Centre and involves single masking with randomized allocation to groups.
CONDITIONS
Brief Title
Screening Using Portable Electronic Recorders for Sleep Apnea in Hypertensive At-Risk Populations (SUPER-SHARP Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with hypertension, defined as uncontrolled blood pressure on or off medications, or controlled blood pressure with two or more blood-pressure lowering medications
- At high risk for obstructive sleep apnea by having a STOP-BANG score of 3 or higher
- Or having concomitant renal disease with estimated glomerular filtration rate (eGFR) between 15 and 59
- Or having resistant hypertension defined as blood pressure above target despite three or more blood pressure-lowering drugs at optimal doses, preferably including a diuretic
You will not qualify if you...
- Prior diagnosis of obstructive sleep apnea
- Current use of continuous positive airway pressure (CPAP) therapy
- Life expectancy less than 6 months
- Estimated glomerular filtration rate (eGFR) less than 15
- Gestational hypertension or preeclampsia
- Current use of dialysis
- Physical, cognitive, or language impairments that prevent completing study assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants undergo diagnostic testing using either a home sleep apnea test or in-laboratory polysomnography to detect obstructive sleep apnea.
1 to 2 visits depending on assigned diagnostic test
Duration - 6 months
Participants are monitored for treatment outcomes including use of CPAP therapy, blood pressure changes, sleep quality, daytime sleepiness, and satisfaction with sleep testing.
Periodic follow-up visits during 6 months
Trial Site Locations
Total: 3 locations
1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5
Actively Recruiting
2
Women's College Hospital
Toronto, Ontario, Canada, M5S 1B2
Not Yet Recruiting
3
Citrus Medical Clinic
Toronto, Ontario, Canada, M8V 0B1
Actively Recruiting
Research Team
M
Mark I Boulos, MD, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here