Home vs Lab Sleep Apnea Testing for High Blood Pressure

(SUPER-SHARP Trial)

Recruiting at 2 trial locations

Overseen By Mark I Boulos, MD, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Must be taking: Blood-pressure lowering

Disqualifiers: Prior OSA, CPAP use, Dialysis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 6 months

190 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two methods for diagnosing sleep apnea in individuals with high blood pressure. It compares the Home Sleep Apnea Test (HSAT) with In-laboratory polysomnography (iPSG) to determine which method results in more diagnoses and better treatment outcomes with a CPAP machine. The goal is to assess whether home tests are as effective, and potentially more convenient and cost-effective. Suitable candidates for this trial have high blood pressure that is difficult to control or require multiple medications to manage, and are at high risk for sleep apnea. As an unphased trial, this study provides a unique opportunity to contribute to research that could make diagnosing sleep apnea more accessible and affordable.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It seems likely that you can continue your blood pressure medications, as the study includes people with controlled blood pressure on medications.

What prior data suggests that home sleep apnea testing is safe for diagnosing obstructive sleep apnea?

Research has shown that home sleep apnea tests safely identify obstructive sleep apnea (OSA). These tests are effective for various individuals and provide valuable sleep health information. Studies indicate that home test results are comparable to those from traditional lab tests, commonly used to diagnose sleep apnea.

No major issues have been reported with home sleep apnea testing. Most people find it comfortable, and it involves no invasive procedures. This makes it a safe option for those who might find traditional lab testing inconvenient or difficult to access. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two different methods for diagnosing obstructive sleep apnea (OSA) in people with high blood pressure. Traditionally, OSA is diagnosed using in-laboratory polysomnography, which requires an overnight stay at a sleep center. However, the home sleep apnea test offers a much more convenient alternative, allowing patients to undergo testing in the comfort of their own homes. This could make it easier for more people to get diagnosed and treated sooner, potentially improving their health outcomes.

What evidence suggests that this trial's treatments could be effective for diagnosing sleep apnea in patients with high blood pressure?

Research shows that obstructive sleep apnea (OSA) is a major risk factor for high blood pressure. Studies have found that using a continuous positive airway pressure (CPAP) machine to treat OSA can help lower blood pressure. This trial compares home sleep apnea tests, which participants in one arm will undergo, to sleep studies conducted in a lab, which participants in another arm will receive. Although some research suggests differences in test accuracy, home tests have proven reliable and may offer more convenience and affordability. The trial aims to determine if home testing improves the diagnosis and treatment of OSA, potentially leading to better blood pressure control and higher patient satisfaction. ^{4 6 7 8 9}

Who Is on the Research Team?

Mark I Boulos, MD, MSc

Principal Investigator

University of Toronto and Sunnybrook Health Sciences Centre

Are You a Good Fit for This Trial?

The SUPER-SHARP Trial is for people with high blood pressure who may also have sleep apnea. Participants should be at risk for obstructive sleep apnea based on a screening tool or have related health issues like kidney disease or resistant hypertension. It's not for those already using CPAP, on dialysis, with gestational hypertension, short life expectancy, or barriers to completing study tasks.

Inclusion Criteria

I am at high risk for sleep apnea or have kidney disease or hard-to-control high blood pressure.

My blood pressure is high, even with medication.

Exclusion Criteria

I have been diagnosed with obstructive sleep apnea.

Your kidney function is very low.

You are currently using a CPAP machine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Assessment

Participants undergo assessment for obstructive sleep apnea using either home sleep apnea test or in-laboratory polysomnography

6 months

1 visit (in-person) for in-laboratory polysomnography or home testing

Treatment

Participants diagnosed with OSA receive treatment using CPAP

6 months

Follow-up

Participants are monitored for changes in blood pressure, sleep-related outcomes, and patient satisfaction

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Home Sleep Apnea Test
• In-laboratory polysomnography

Trial Overview This trial compares two methods of diagnosing sleep apnea in people with high blood pressure: traditional in-lab overnight tests (polysomnography) and home-based portable tests. The goal is to see if the home test leads to more diagnoses and treatments of sleep apnea, better blood pressure control, improved patient satisfaction, and cost-effectiveness after 6 months.

How Is the Trial Designed?

Group I: Home Sleep Apnea Test Experimental Treatment 1 Intervention

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

Group II: In-laboratory Polysomnography Active Control 1 Intervention

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

Home Sleep Apnea Test is already approved in United States, European Union for the following indications:

Approved in United States as Home Sleep Apnea Testing for:

• Diagnosis of Obstructive Sleep Apnea

Approved in European Union as Home Sleep Apnea Testing for:

• Diagnosis of Obstructive Sleep Apnea

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Women's College Hospital

Collaborator

Trials

108

Recruited

43,700+

Published Research Related to This Trial

In a study of 141 patients who had a negative polysomnography (PSG) for obstructive sleep apnea (OSA), 83.7% were diagnosed with OSA using a subsequent home sleep apnea test (HSAT), indicating that PSG can sometimes yield false negatives.

Older age and the presence of hypertension were significant predictors for a positive OSA diagnosis on HSAT after an initial negative PSG, suggesting that these factors should be considered when evaluating patients for repeat testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Obstructive Sleep Apnea on a Home Sleep Apnea Test After a Negative Attended Polysomnography. Lipatov, K., Hayek, A., Ghamande, S., et al.[2019]

In a study of 56 patients suspected of having obstructive sleep apnea, peripheral arterial tonometry (PAT) was found to result in less time spent in the supine position compared to cardio-respiratory polygraphy (RP), which may be beneficial for certain patients.

Patients reported greater comfort and fewer disturbances during sleep with PAT, leading to 80% of participants preferring PAT over RP for future testing, along with a lower rate of technical failures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep position, patient comfort, and technical performance with two established procedures for home sleep testing. Mueller, CE., Li, H., Begasse, SM., et al.[2022]

In a study of 238 patients who underwent home sleep testing (HST) followed by polysomnography (PSG), 76% of those with a normal HST had a normal PSG, indicating that younger patients with normal HST results are likely to not have obstructive sleep apnea (OSA).

Conversely, among patients with a technical inadequate (TI) HST, 71% were diagnosed with OSA on subsequent PSG, highlighting the importance of PSG for confirming OSA in cases where HST results are inconclusive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Obstructive Sleep Apnea on Polysomnography after a Technically Inadequate or Normal Home Sleep Test. Zeidler, MR., Santiago, V., Dzierzewski, JM., et al.[2018]

In a study of 198 patients, automatic analysis (AA) of home sleep apnea testing (HSAT) showed moderate concordance with manual analysis (MA) for diagnosing obstructive sleep apnea hypopnea syndrome (OSAHS), but weak concordance for severity classification, indicating potential inaccuracies in AA.

The AA underestimated the apnea-hypopnea index (AHI) by an average of 8 events per hour and misclassified the severity of OSAHS in 47% of cases, suggesting that reliance on AA could lead to inappropriate treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences between manual and automatic analysis in determining the severity of obstructive sleep apnea using home sleep apnea testing. Labarca, G., Dreyse, J., Salas, C., et al.[2019]

In a feasibility study involving 21 patients, home-polysomnography (HPSG) using telematic technologies showed a high success rate, with 90% of recordings being of excellent quality and only a 10% failure rate.

The use of real-time monitoring via Skype® allowed for effective troubleshooting of issues, demonstrating that remote support can enhance the reliability of home sleep studies, although some technical improvements are still needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time attended home-polysomnography with telematic data transmission. Bruyneel, M., Van den Broecke, S., Libert, W., et al.[2013]

In a study of 2563 sleep apnea patients, those who underwent in-lab polysomnography (PSG) reported higher satisfaction with their testing experience (71%) compared to those who had home sleep apnea testing (HSAT) (60%), indicating a significant difference in patient acceptance between the two methods.

The study found that patients with HSAT had 38% lower odds of satisfaction compared to those with PSG, even after adjusting for factors like symptom severity and CPAP satisfaction, suggesting that real-world experiences may differ from previous research findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient satisfaction with sleep study experience: findings from the Sleep Apnea Patient-Centered Outcomes Network. Kapur, VK., Johnston, JC., Rueschman, M., et al.[2020]

Type IV portable monitors (PMs) show variable sensitivity (67.5-100%) and specificity (25-100%) for diagnosing obstructive sleep apnea (OSA) compared to the gold standard polysomnography (PSG), indicating that while they can be useful, their accuracy may not be reliable enough for standalone clinical use.

The review included 24 studies with 2068 patients, suggesting that while type IV PMs could improve access to OSA diagnosis, careful consideration of their diagnostic limitations is necessary to avoid potential misdiagnoses that could impact patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic accuracy of level IV portable sleep monitors versus polysomnography for obstructive sleep apnea: a systematic review and meta-analysis. Abrahamyan, L., Sahakyan, Y., Chung, S., et al.[2019]

In a study of 102 patients who had a stroke or transient ischemic attack (TIA), 80.4% were able to provide analyzable sleep data using home sleep apnea testing (HSAT), demonstrating its feasibility as a screening tool for obstructive sleep apnea (OSA).

OSA was detected in 63.4% of patients with analyzable data, and 65.4% of those diagnosed initiated continuous positive airway pressure (CPAP) therapy, indicating that HSAT can facilitate timely diagnosis and treatment of OSA in stroke or TIA patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unattended Hospital and Home Sleep Apnea Testing Following Cerebrovascular Events. Boulos, MI., Elias, S., Wan, A., et al.[2019]

Citations

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Obstructive sleep apnea and hypertension; critical overview In particular, numerous studies have suggested that a pathological sleep disorder such as OSA is an independent risk factor for hypertension.

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Obstructive sleep apnea -related hypertension: a review of ... Systolic BP (SBP) and diastolic BP (DBP) reduce by ~10 mmHg (about 10–20%) during sleep, but this dipping phenomenon is reversed in those with ...

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Obstructive Sleep Apnea and Cardiometabolic Disease A landmark study of longitudinal data from the Wisconsin Sleep Cohort showed that worsening AHI increases the likelihood of hypertension at ...

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Sleep Testing for Obstructive Sleep Apnea (OSA) CMS finds that the evidence is sufficient to determine that the results of the sleep tests identified below can be used by a beneficiary's treating physician ...

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Agreement between Results of Home Sleep Testing for ... Obstructive sleep apnea can be reliably identified with home sleep testing in a non-referred sample irrespective of the pretest probability of the disease.

7. aasm.org aasm.org/aasm-releases-position-statement-home-sleep-apnea-testing/

AASM Home Sleep Apnea Testing (HSAT) Position ... “A home sleep apnea test provides valuable information for the diagnostic assessment of certain patients with suspected obstructive sleep apnea, ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10758567/

Long-term health outcomes for patients with obstructive sleep ... This multisociety commentary critically examines the Agency for Healthcare Research and Quality (AHRQ) final report and systematic review on long-term health ...

9. uptodate.com uptodate.com/contents/home-sleep-apnea-testing-for-obstructive-sleep-apnea-in-adults

Home sleep apnea testing for obstructive sleep apnea in adults Limited data suggest comparable clinical outcomes when type 3 and type one devices were compared [3]. In-laboratory devices. Type 1 devices ( ...