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Procedure

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
Must not have
Prior diagnosis of OSA
Current use of dialysis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My blood pressure is high, even with medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been diagnosed with obstructive sleep apnea.
Select...
I am currently undergoing dialysis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Diagnosis of OSA
Secondary study objectives
Change in 24-hour ambulatory blood pressure
Daytime Sleepiness (as assessed by the Epworth Sleepiness Scale)
Patient satisfaction with sleep testing
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
106 Previous Clinical Trials
43,371 Total Patients Enrolled
Sunnybrook Health Sciences CentreLead Sponsor
674 Previous Clinical Trials
1,565,299 Total Patients Enrolled
Mark I Boulos, MD, MScPrincipal InvestigatorUniversity of Toronto and Sunnybrook Health Sciences Centre
2 Previous Clinical Trials
450 Total Patients Enrolled

Media Library

Home Sleep Apnea Test (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05918120 — N/A
High Blood Pressure Research Study Groups: Home Sleep Apnea Test, In-laboratory Polysomnography
High Blood Pressure Clinical Trial 2023: Home Sleep Apnea Test Highlights & Side Effects. Trial Name: NCT05918120 — N/A
Home Sleep Apnea Test (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05918120 — N/A
~38 spots leftby Mar 2025
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