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

Not Applicable

Recruiting

• Conditions: Obstructive Sleep Apnea; Hypertension
• Interventions: Device: In-laboratory polysomnography; Device: Home Sleep Apnea Test

• Registration Number: NCT05918120
• Lead Sponsor: Sunnybrook Health Sciences Centre

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-15
• Study First Submitted QC: 2023-06-15
• Study First Posted: 2023-06-26
• Study Start: 2023-11-13
• Status Verified: 2025-01
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-11
• Primary Completion: 2025-12-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 190

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
In-laboratory Polysomnography	In-laboratory polysomnography	Patients receive standard of care for diagnosing obstructive sleep apnea, which is in-laboratory polysomnography.
Home Sleep Apnea Test	Home Sleep Apnea Test	Patients will undergo assessment for obstructive sleep apnea using a home sleep apnea test.

Primary Outcome Measures

Name	Time	Method
Diagnosis of OSA	6 months	The investigators will track the number of subjects in each arm who are diagnosed with OSA. Subjects who withdraw or are lost to follow-up without receiving a diagnosis of OSA will be included in our analysis as not having received an OSA diagnosis.

Secondary Outcome Measures

Name	Time	Method
Treatment using CPAP	6 months	The proportion of patients treated for OSA using CPAP
Daytime Sleepiness (as assessed by the Epworth Sleepiness Scale)	6 months	Daytime Sleepiness (as assessed by the Epworth Sleepiness Scale) at 6 months. Scores on Epworth Sleepiness Scale range from range from 0 to 24, with higher scores indicating higher average sleep propensity in daily life (daytime sleepiness).
Change in 24-hour ambulatory blood pressure	6 months	Change in 24-hour ambulatory blood pressure from baseline to 6 months
Sleep-related quality of life (as assessed by the Functional Outcomes of Sleep Questionnaire)	6 months	Sleep-related quality of life (as assessed by the Functional Outcomes of Sleep Questionnaire) at 6 months. Functional Outcomes of Sleep Questionnaire (FOSQ) encompasses 5 subscales: activity level, vigilance, intimacy and sexual relationships, general productivity, social outcome. An average score is calculated for each subscale and the 5 subscales are totaled to produce a total score. Subscale scores range from 1-4 with total scores ranging from 5-20. Higher scores indicate better functional status.
Patient satisfaction with sleep testing	6 months	Patient satisfaction for each strategy and treatment (as assessed by a Likert scale) at 6 months. Scores range from 0-16, with higher scores indicating increased satisfaction.

Trial Locations

Locations (3)

Citrus Medical Clinic; 🇨🇦 Toronto, Ontario, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

Women's College Hospital; 🇨🇦 Toronto, Ontario, Canada