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

NCT ID: NCT05918120

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-13
• Study Completion Date: 2026-05-01

Brief 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.

Conditions

Obstructive Sleep Apnea; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Home Sleep Apnea Test

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

Group Type: EXPERIMENTAL

Home Sleep Apnea Test

Intervention Type: DEVICE

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.

In-laboratory Polysomnography

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

Group Type: ACTIVE_COMPARATOR

In-laboratory polysomnography

Intervention Type: DEVICE

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

Interventions

Home 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.

Intervention Type: DEVICE

In-laboratory polysomnography

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

Intervention Type: DEVICE

Other Intervention Names

HSAT; iPSG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Women's College Hospital

OTHER

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark I Boulos, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Toronto and Sunnybrook Health Sciences Centre

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status: RECRUITING

Women's College Hospital

Toronto, Ontario, Canada

Site Status: NOT_YET_RECRUITING

Citrus Medical Clinic

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Mark I Boulos, MD, MSc

Role: CONTACT

mark.boulos@sunnybrook.ca

4164804473

Facility Contacts

Mark I Boulos, MD, MSc

Role: primary

mark.boulos@utoronto.ca

4164804473

Sachin Pasricha, MD

Role: primary

spasricha@qmed.ca

416-800-6500

Other Identifiers

5749

Identifier Type: -

Identifier Source: org_study_id