Clinical trial NCT05918120: Screening Using Portable Electronic Recorders for Sleep Apnea in Hypertensive At-Risk Populations (SUPER-SHARP Trial)
Official title: Screening Using Portable Electronic Recorders for Sleep Apnea in Hypertensive At-Risk Populations (SUPER-SHARP Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Hypertension
Keywords: Home Sleep Apnea Tests
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Women's College Hospital
First posted: 2023-06-26
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Diagnosis of OSA
timeFrame: 6 months
Secondary outcomes:
measure: Treatment using CPAP
timeFrame: 6 months
measure: Change in 24-hour ambulatory blood pressure
timeFrame: 6 months
measure: Sleep-related quality of life (as assessed by the Functional Outcomes of Sleep Questionnaire)
timeFrame: 6 months
measure: Daytime Sleepiness (as assessed by the Epworth Sleepiness Scale)
timeFrame: 6 months
measure: Patient satisfaction with sleep testing
timeFrame: 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
city: Toronto
country: Canada
facility: Citrus Medical Clinic
state: Ontario
Study officials:
affiliation: University of Toronto and Sunnybrook Health Sciences Centre
name: Mark I Boulos, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: