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Sleep Apnea

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT05918120

Conditions

Obstructive Sleep Apnea

Hypertension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Home Sleep Apnea Test

In-laboratory polysomnography

Study Details

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

Study ID

NCT05918120

Start date

Nov 13, 2023

Status verified date

Aug, 2026

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

190 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Home Sleep Apnea Test

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

active comparator: In-laboratory Polysomnography

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

Interventions

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.

In-laboratory polysomnography

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

Primary outcome measure

  • Diagnosis of OSA [ Time Frame: 6 months ]

Central Contacts and Locations

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

  • Home Sleep Apnea Tests

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-22. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2026-08-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.