Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05918120

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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