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Home vs Lab Sleep Apnea Testing for High Blood Pressure (SUPER-SHARP Trial)
N/A
Recruiting
Led By Mark I Boulos, MD, MSc
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Hypertension, defined as uncontrolled blood pressure on or off medications, or controlled blood pressure on 2 or more blood-pressure lowering medications
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
SUPER-SHARP Trial Summary
This trial seeks to compare the effectiveness of home sleep apnea testing to in-lab testing to diagnose & treat obstructive sleep apnea, linked to increased risk of heart disease, stroke & mortality in patients with hypertension.
Who is the study for?
The SUPER-SHARP Trial is for people with high blood pressure who may also have sleep apnea. Participants should be at risk for obstructive sleep apnea based on a screening tool or have related health issues like kidney disease or resistant hypertension. It's not for those already using CPAP, on dialysis, with gestational hypertension, short life expectancy, or barriers to completing study tasks.Check my eligibility
What is being tested?
This trial compares two methods of diagnosing sleep apnea in people with high blood pressure: traditional in-lab overnight tests (polysomnography) and home-based portable tests. The goal is to see if the home test leads to more diagnoses and treatments of sleep apnea, better blood pressure control, improved patient satisfaction, and cost-effectiveness after 6 months.See study design
What are the potential side effects?
Since this trial involves diagnostic testing rather than medication or invasive procedures, side effects are minimal but may include discomfort from wearing the testing equipment during sleep.
SUPER-SHARP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood pressure is high, even with medication.
SUPER-SHARP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Diagnosis of OSA
Secondary outcome measures
Change in 24-hour ambulatory blood pressure
Daytime Sleepiness (as assessed by the Epworth Sleepiness Scale)
Patient satisfaction with sleep testing
+2 moreSUPER-SHARP Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Home Sleep Apnea TestExperimental Treatment1 Intervention
Patients will undergo assessment for obstructive sleep apnea using a home sleep apnea test.
Group II: In-laboratory PolysomnographyActive Control1 Intervention
Patients receive standard of care for diagnosing obstructive sleep apnea, which is in-laboratory polysomnography.
Find a Location
Who is running the clinical trial?
Women's College HospitalOTHER
101 Previous Clinical Trials
38,902 Total Patients Enrolled
Sunnybrook Health Sciences CentreLead Sponsor
656 Previous Clinical Trials
1,551,117 Total Patients Enrolled
Mark I Boulos, MD, MScPrincipal InvestigatorUniversity of Toronto and Sunnybrook Health Sciences Centre
2 Previous Clinical Trials
450 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with obstructive sleep apnea.I am at high risk for sleep apnea or have kidney disease or hard-to-control high blood pressure.Your kidney function is very low.You are currently using a CPAP machine.I am currently undergoing dialysis.My blood pressure is high, even with medication.You have high blood pressure during pregnancy or a condition called preeclampsia.You are not expected to live for more than 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Home Sleep Apnea Test
- Group 2: In-laboratory Polysomnography
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants still being sought out for this research initiative?
"According to the clinicaltrials.gov portal, this trial is not presently open for recruitment and was last updated on June 15th 2023. However, there are a plethora of alternate studies that are currently signing up participants - 983 in total!"
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