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NCT05918120Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 20 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
190 (estimated)
First submitted
15 Jun 2023
Start date
13 Nov 2023
Primary completion date
1 Sept 2026
Lead sponsor
Sunnybrook Health Sciences Centre
NCT number
NCT05918120

What you commit to

  • Study type: Interventional
  • Planned participants: 190
  • From 13 Nov 2023 to the primary completion date, 1 Sept 2026
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Lab values

  • 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.

Who the study is looking for

  • (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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Citrus Medical Clinic
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status
Women's College Hospital
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status
Sunnybrook Health Sciences Centre
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.