RecruitingNot ApplicableNCT05918120

Screening Using Portable Electronic Recorders for Sleep Apnea in Hypertensive At-Risk Populations (SUPER-SHARP Trial)


Sponsor

Sunnybrook Health Sciences Centre

Enrollment

190 participants

Start Date

Nov 13, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (SUPER-SHARP) is studying whether a portable home sleep monitor can effectively screen for obstructive sleep apnea — a condition where breathing repeatedly stops during sleep — in people with high blood pressure who are at increased risk. Sleep apnea is often undiagnosed and can make high blood pressure harder to control. **You may be eligible if:** - You have high blood pressure (either uncontrolled, or controlled only with two or more blood pressure medications) - You are at high risk for sleep apnea — for example, you scored 3 or higher on the STOP-BANG questionnaire, have chronic kidney disease, or have blood pressure that stays high despite three or more medications **You may NOT be eligible if:** - You have already been diagnosed with obstructive sleep apnea - You currently use a CPAP machine - Your life expectancy is less than 6 months - Your kidney function is severely impaired (eGFR below 15) - You have high blood pressure related to pregnancy (gestational hypertension or preeclampsia) - You are currently on dialysis - You have physical, cognitive, or language barriers that prevent you from completing the study assessments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHome Sleep Apnea Test

Use of a home sleep apnea test that records respiratory effort, pulse, oxygen saturation and nasal flow, and reports apneas, hypopneas, flow limitation, snoring and blood oxygen saturation in order to detect obstructive sleep apnea.

DEVICEIn-laboratory polysomnography

Level 1 in-laboratory polysomnography for the detection of obstructive sleep apnea.


Locations(3)

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Women's College Hospital

Toronto, Ontario, Canada

Citrus Medical Clinic

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

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NCT05918120


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