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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of home sleep apnea testing (HSAT) for high blood pressure treatment?

Home sleep apnea testing (HSAT) is a recognized alternative to in-laboratory polysomnography (PSG) for diagnosing obstructive sleep apnea (OSA), which is often linked to high blood pressure. Studies suggest that HSAT is effective in identifying OSA in high-risk patients, which can help manage related conditions like high blood pressure. ^{1 2 3 4 5}

Is home sleep apnea testing safe for humans?

The research does not specifically address safety concerns, but home sleep apnea testing (HSAT) is widely used as an alternative to lab-based tests for diagnosing sleep apnea, suggesting it is generally considered safe for humans. ^{1 2 3 6 7}

How does the treatment for sleep apnea testing differ from other treatments for high blood pressure?

Home Sleep Apnea Testing (HSAT) and In-laboratory polysomnography (PSG) are unique because they focus on diagnosing sleep apnea, which can contribute to high blood pressure. Unlike typical high blood pressure treatments that involve medication, these tests help identify sleep-related breathing issues that might be causing or worsening the condition, allowing for targeted interventions. ^{1 2 3 5 8}

Research Team

Mark I Boulos, MD, MSc

Principal Investigator

University of Toronto and Sunnybrook Health Sciences Centre

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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 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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Predictors of Obstructive Sleep Apnea on Polysomnography after a Technically Inadequate or Normal Home Sleep Test. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Predictors of Obstructive Sleep Apnea on a Home Sleep Apnea Test After a Negative Attended Polysomnography. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Patient satisfaction with sleep study experience: findings from the Sleep Apnea Patient-Centered Outcomes Network. [2020]

4. Ireland pubmed.ncbi.nlm.nih.gov

Real-time attended home-polysomnography with telematic data transmission. [2013]

5. Germany pubmed.ncbi.nlm.nih.gov

Sleep position, patient comfort, and technical performance with two established procedures for home sleep testing. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Unattended Hospital and Home Sleep Apnea Testing Following Cerebrovascular Events. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Differences between manual and automatic analysis in determining the severity of obstructive sleep apnea using home sleep apnea testing. [2019]

8. Germany 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. [2019]