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

NCT05918120 | Recruiting

• 1 other identifier: 5749
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 3

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

Keywords

Home Sleep Apnea Tests

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Treatment using CPAP

  6 months

• Change in 24-hour ambulatory blood pressure

  6 months

• Sleep-related quality of life (as assessed by the Functional Outcomes of Sleep Questionnaire)

  6 months

• Daytime Sleepiness (as assessed by the Epworth Sleepiness Scale)

  6 months

• Patient satisfaction with sleep testing

  6 months

Study Arms (2)

Home Sleep Apnea Test

EXPERIMENTAL

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

Device: Home Sleep Apnea Test

In-laboratory Polysomnography

ACTIVE COMPARATOR

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

Device: In-laboratory polysomnography

Interventions

Home Sleep Apnea Test 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.

Also known as: HSAT

Home Sleep Apnea Test

In-laboratory polysomnography DEVICE

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

Also known as: iPSG

In-laboratory Polysomnography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Women's College Hospital: collaborator

Study Sites (3)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

RECRUITING

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

NOT YET RECRUITING

Citrus Medical Clinic

Toronto, Ontario, M8V 0B1, Canada

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Hypertension

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mark I Boulos, MD, MSc

  University of Toronto and Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark I Boulos, MD, MSc

CONTACT

4164804473; mark.boulos@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: June 26, 2023
• Study Start: November 13, 2023
• Primary Completion: December 1, 2025
• Study Completion: May 1, 2026
• Last Updated: February 11, 2025

Record last verified: 2025-01

Locations

CA (3)