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
128 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
Uncontrolled hypertension is associated with an increased risk of heart disease, stroke, and mortality. Obstructive sleep apnea (OSA) is common in hypertension and treatment using continuous positive airway pressure (CPAP) has been shown to effectively lower blood pressure. Despite its clinical significance, OSA remains underdiagnosed in patients with hypertension, because the current standard of care to diagnose OSA is in-laboratory polysomnography, which is inconvenient and often inaccessible for high-risk populations. An alternative to in-laboratory polysomnography is home sleep apnea testing, which has been validated against in-laboratory polysomnography and may be more convenient, accessible, and potentially cost-effective. The objective of this study is to compare home sleep apnea testing to in-laboratory polysomnography in a randomized controlled trial. The investigators will assess whether the use of home sleep apnea testing, compared to use of in-laboratory polysomnography, leads to higher rates of OSA diagnosis and treatment using CPAP, a reduction in blood pressure, improved sleep-related outcomes, and greater patient satisfaction among patients with hypertension at 6 months. The investigators will also assess whether home testing is cost-effective.
CONDITIONS
Official 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...
- Hypertension defined as uncontrolled blood pressure on or off medications, or controlled blood pressure using two or more blood pressure-lowering medications
- High risk for obstructive sleep apnea as shown by STOP-BANG screening score of 3 or higher, or presence of renal disease with eGFR 15-59, or resistant hypertension despite optimal doses of three or more blood pressure drugs including a diuretic
You will not qualify if you...
- Prior diagnosis of obstructive sleep apnea or current use of CPAP therapy
- Life expectancy less than 6 months
- Kidney function with eGFR less than 15
- Gestational hypertension or preeclampsia
- Current use of dialysis
- Physical or cognitive impairments or language barriers that prevent completing study assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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