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

Sunnybrook Health Sciences Centre

Status: Enrolling

Conditions: Hypertension; Obstructive Sleep Apnea

Treatments: Device: In-laboratory polysomnography; Device: Home Sleep Apnea Test

Study type: Interventional

Funder types: Other

Identifiers

NCT05918120

5749

Details and patient eligibility

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.

Enrollment: 190 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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190 participants in 2 patient groups

Home Sleep Apnea Test

Experimental group

Description:

Patients will undergo assessment for obstructive sleep apnea using a home sleep apnea test.

Treatment:

Device: Home Sleep Apnea Test

In-laboratory Polysomnography

Active Comparator group

Description:

Patients receive standard of care for diagnosing obstructive sleep apnea, which is in-laboratory polysomnography.

Treatment:

Device: In-laboratory polysomnography