Obstructive Sleep ApneaSUPER-SHARPNCT05918120
Screening Using Portable Electronic Recorders for Sleep Apnea in Hypertensive At-Risk Populations (SUPER-SHARP Trial)
A study testing Home Sleep Apnea Test and In-laboratory polysomnography in people with Obstructive Sleep Apnea and Hypertension, run by Sunnybrook Health Sciences Centre at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Hypertension
- What is being tested?
- Home Sleep Apnea Test and In-laboratory polysomnography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 3 sitesCanada
- Study dates
- 13 Nov 2023to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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)
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5
Women's College Hospital
Toronto, Ontario, M5S 1B2
Citrus Medical Clinic
Toronto, Ontario, M8V 0B1
About this study
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
- Being tested
- Home Sleep Apnea Test, In-laboratory polysomnography
- Keywords
- Home Sleep Apnea Tests
- Medical subject headings
- Sleep Apnea, Obstructive, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Sleep Apnea TestDevice
Also called HSAT
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 polysomnographyDevice
Also called iPSG
Level 1 in-laboratory polysomnography for the detection of obstructive sleep apnea.
| Study group | Role | What they receive |
|---|---|---|
| Home Sleep Apnea Test | Experimental | Patients will undergo assessment for obstructive sleep apnea using a home sleep apnea test. Receives: 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. Receives: Device: In-laboratory polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (5)
Treatment using CPAP
The proportion of patients treated for OSA using CPAP
Measured: 6 months
Change in 24-hour ambulatory blood pressure
Change in 24-hour ambulatory blood pressure from baseline to 6 months
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start13 Nov 2023
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Women's College Hospital
- Responsible party
- Sponsor
- Investigators
- Mark I Boulos, MD, MSc, Principal investigator, University of Toronto and Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05918120
- Sponsor's protocol ID
- 5749
- Acronym
- SUPER-SHARP
- Status last verified
- Aug 2026
- First submitted
- 15 Jun 2023
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Using Portable Electronic Recorders for Sleep Apnea in Hypertensive At-Risk Populations (SUPER-SHARP Trial)
- ClinicalTrials.gov ID
- NCT05918120
- Acronym / sponsor ID
- SUPER-SHARP / 5749
- Conditions
- Obstructive Sleep Apnea, Hypertension
- Keywords
- Home Sleep Apnea Tests
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Women's College Hospital
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 26 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home Sleep Apnea Test | Experimental | Device: Home Sleep Apnea TestPatients will undergo assessment for obstructive sleep apnea using a home sleep apnea test. |
| In-laboratory Polysomnography | Active comparator | Device: In-laboratory polysomnographyPatients receive standard of care for diagnosing obstructive sleep apnea, which is in-laboratory polysomnography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- (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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home Sleep Apnea TestAlso: HSATUse 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. | Device | Home Sleep Apnea Test |
| In-laboratory polysomnographyAlso: iPSGLevel 1 in-laboratory polysomnography for the detection of obstructive sleep apnea. | Device | In-laboratory Polysomnography |
Primary outcome
Diagnosis of OSA
Time frame: 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.
5 secondary outcomes
Treatment using CPAP
Time frame: 6 months
Change in 24-hour ambulatory blood pressure
Time frame: 6 months
Sleep-related quality of life (as assessed by the Functional Outcomes of Sleep Questionnaire)
Time frame: 6 months
Daytime Sleepiness (as assessed by the Epworth Sleepiness Scale)
Time frame: 6 months
Patient satisfaction with sleep testing
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark I Boulos, MD, MSc principal investigator
University of Toronto and Sunnybrook Health Sciences Centre
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Sleep Apnea Test and In-laboratory polysomnography in people with Obstructive Sleep Apnea and Hypertension, run by Sunnybrook Health Sciences Centre at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of OSA (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.