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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• (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)

Locations
Other Locations
Canada
Citrus Medical Clinic
RECRUITING
Toronto
Sunnybrook Health Sciences Centre
RECRUITING
Toronto
Women's College Hospital
NOT_YET_RECRUITING
Toronto
Contact Information
Primary
Mark I Boulos, MD, MSc
mark.boulos@sunnybrook.ca
4164804473
Time Frame
Start Date: 2023-11-13
Estimated Completion Date: 2026-05-01
Participants
Target number of participants: 190
Treatments
Experimental: Home Sleep Apnea Test
Patients will undergo assessment for obstructive sleep apnea using a home sleep apnea test.
Active_comparator: In-laboratory Polysomnography
Patients receive standard of care for diagnosing obstructive sleep apnea, which is in-laboratory polysomnography.
Sponsors
Leads: Sunnybrook Health Sciences Centre
Collaborators: Women's College Hospital

This content was sourced from clinicaltrials.gov