Screening for sleep apnea in people with high blood pressure
Screening Using Portable Electronic Recorders for Sleep Apnea in Hypertensive At-Risk Populations (SUPER-SHARP Trial)
This study is testing if home sleep tests for sleep apnea are just as good as hospital tests for people with high blood pressure to help them get diagnosed more easily.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 190 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Locations | 3 sites (Toronto, Ontario and 2 other locations) |
| Trial ID | NCT05918120 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of home sleep apnea testing to traditional in-laboratory polysomnography for diagnosing obstructive sleep apnea (OSA) in patients with hypertension. Given that OSA is often underdiagnosed in this population, the study will assess whether home testing can provide a more accessible and convenient alternative. Participants will be randomly assigned to either the home testing group or the in-laboratory group, and outcomes will be measured to determine the accuracy and feasibility of home testing. The goal is to improve diagnosis rates of OSA in hypertensive patients, potentially leading to better management of their condition.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with hypertension who are at high risk for obstructive sleep apnea, as indicated by specific screening tools or medical conditions.
Not a fit: Patients who have already been diagnosed with obstructive sleep apnea or are currently using CPAP therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and treatment of obstructive sleep apnea in patients with hypertension, ultimately reducing their risk of heart disease and stroke.
How similar studies have performed: Previous studies have shown that home sleep apnea testing can be a valid alternative to in-laboratory polysomnography, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * (1) Hypertension, defined as: * uncontrolled blood pressure on or off medications, or * controlled blood pressure on 2 or more blood-pressure lowering medications * (2) At high risk for OSA: * STOP-BANG sleep apnea screening tool ≥3, or * Concomitant renal disease (estimated glomerular filtration rate \[eGFR\] 15-59), or * Resistant hypertension, defined as a blood pressure above target despite 3 or more BP-lowering drugs at optimal doses (preferably including a diuretic) Exclusion Criteria: * prior diagnosis of OSA, current use of CPAP, life expectancy less than 6 months, eGFR\<15, gestational hypertension or preeclampsia, current use of dialysis, and physical/cognitive impairment/language barrier restricting the ability to complete the study assessments.
Where this trial is running
Toronto, Ontario and 2 other locations
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)
- Women's College Hospital — Toronto, Ontario, Canada (Not_yet_recruiting)
- Citrus Medical Clinic — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Mark I Boulos, MD, MSc — University of Toronto and Sunnybrook Health Sciences Centre
- Study coordinator: Mark I Boulos, MD, MSc
- Email: mark.boulos@sunnybrook.ca
- Phone: 4164804473
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.