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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension; Obstructive Sleep Apnea
• Intervention / Treatment: Device: In-laboratory polysomnography; Device: Home Sleep Apnea Test

• Study Type: Interventional
• Enrollment (Estimated): 190
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mark I Boulos, MD, MSc; Phone Number: 4164804473; Email: mark.boulos@sunnybrook.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N3M5
      • Recruiting
      • Sunnybrook Health Sciences Centre
      • Contact: Mark I Boulos, MD, MSc; Phone Number: 4164804473; Email: mark.boulos@utoronto.ca
    • Toronto, Ontario, Canada, M5S 1B2
      • Not yet recruiting
      • Women's College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home Sleep Apnea Test; Patients will undergo assessment for obstructive sleep apnea using a home sleep apnea test.	Device: 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.; Other Names: HSAT
Active Comparator: In-laboratory Polysomnography; Patients receive standard of care for diagnosing obstructive sleep apnea, which is in-laboratory polysomnography.	Device: In-laboratory polysomnography; Level 1 in-laboratory polysomnography for the detection of obstructive sleep apnea.; Other Names: iPSG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis of OSA	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment using CPAP	The proportion of patients treated for OSA using CPAP	6 months
Change in 24-hour ambulatory blood pressure	Change in 24-hour ambulatory blood pressure from baseline to 6 months	6 months
Sleep-related quality of life (as assessed by the Functional Outcomes of Sleep Questionnaire)	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.	6 months
Daytime Sleepiness (as assessed by the Epworth Sleepiness Scale)	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).	6 months
Patient satisfaction with sleep testing	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.	6 months

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: Women's College Hospital
• Investigators: Principal Investigator: Mark I Boulos, MD, MSc, University of Toronto and Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: June 15, 2023
• First Submitted That Met QC Criteria: June 15, 2023
• First Posted (Actual): June 26, 2023

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 22, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Home Sleep Apnea Tests
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 5749

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No