Home Sleep Apnea Testing for Cognitive Impairment

(ENCHANT Trial)

Overseen By Mark I Boulos, MD, MSc

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Disqualifiers: Prior OSA diagnosis, CPAP use, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a more convenient method for detecting obstructive sleep apnea (OSA) in individuals with cognitive issues such as Alzheimer's or vascular dementia. It compares a home test for sleep apnea (Home Sleep Apnea Test) with the standard lab test to determine which one patients are more likely to complete. The researchers aim to assess whether the home test is more cost-effective and if it improves thinking, mood, and sleep. Suitable participants have memory or cognitive issues and have not been diagnosed with sleep apnea in the past two years. As an unphased trial, this study provides a unique opportunity to contribute to research that could make sleep apnea testing more accessible and beneficial for those with cognitive challenges.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that home sleep apnea testing is safe for patients with cognitive impairment?

Research has shown that testing for sleep apnea at home, known as home sleep apnea testing (HSAT), is safe and effective. Studies have found that HSAT is as reliable as traditional lab-based sleep tests, known as polysomnography, for diagnosing obstructive sleep apnea (OSA). Importantly, people generally find HSAT easy to use. No major side effects have been reported, making it a safe choice for those who might find lab tests inconvenient or uncomfortable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Home Sleep Apnea Test because it offers a more convenient and potentially cost-effective alternative to the standard in-laboratory polysomnography for diagnosing obstructive sleep apnea. Unlike traditional methods where patients must spend the night in a sleep lab, this test allows individuals to be assessed in the comfort of their own home. This could lead to easier access to diagnosis and treatment, especially for those who have difficulty traveling to a clinic or hospital. Additionally, the home-based approach may encourage more people to get tested, potentially identifying cognitive impairments linked to sleep apnea earlier.

What evidence suggests that home sleep apnea testing is effective for diagnosing obstructive sleep apnea in patients with cognitive impairment?

This trial will compare two methods for diagnosing obstructive sleep apnea (OSA) in individuals with memory and thinking problems: Home Sleep Apnea Testing (HSAT) and in-laboratory polysomnography. Research has shown that HSAT is a practical method for detecting OSA, performing as effectively as lab testing. OSA commonly occurs in individuals with memory issues related to blood flow problems and Alzheimer's disease. Treating OSA with a continuous positive airway pressure (CPAP) machine can enhance thinking skills and slow memory loss. The convenience of home testing increases the likelihood of patients completing their sleep tests, which is crucial for initiating treatment. Overall, HSAT can aid in identifying and managing OSA, potentially improving cognitive function and memory in these patients. ^{1 3 4 6 7}

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?

This trial is for individuals with cognitive impairments like Mild Cognitive Impairment or Alzheimer's, and suspected sleep apnea. Participants should have certain cognitive scores (MoCA: 13-28, MMSE: 18-30, TorCA ≤281) and a caregiver if needed. It excludes those already on CPAP therapy for sleep apnea, with recent OSA diagnosis, severe lung/heart conditions affecting the test's accuracy, pacemakers or arrhythmias (for WatchPAT users), or significant physical/language barriers.

Inclusion Criteria

I have been diagnosed with a type of cognitive impairment or dementia, possibly due to Alzheimer's or vascular issues.

Availability of a caregiver to assist in the completion of HSAT or iPSG, if needed

I can make my own medical decisions or have someone who can.

Exclusion Criteria

I was diagnosed with sleep apnea in the last 2 years.

I do not have severe lung or heart issues that could affect sleep study results.

You are currently using a CPAP machine or a dental appliance for diagnosed sleep apnea.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Testing

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

6 months

Treatment

Participants diagnosed with OSA are treated using continuous positive airway pressure (CPAP)

6 months

Follow-up

Participants are monitored for changes in cognition, mood, sleep-related and functional outcomes

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Home Sleep Apnea Test
• In-laboratory polysomnography

Trial Overview The study compares in-laboratory polysomnography (iPSG) to home sleep apnea testing (HSAT) to see which is better at completing sleep tests within six months in patients with vascular cognitive impairment and Alzheimer's disease. It also looks at cost-effectiveness, patient satisfaction, CPAP treatment rates, and changes in cognition and mood.

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: Standard of Care 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+

Unity Health Toronto

Collaborator

Trials

572

Recruited

470,000+

Published Research Related to This Trial

Home sleep apnea testing (HSAT) is becoming more popular for diagnosing obstructive sleep apnea (OSA) due to advancements in technology and changes in insurance coverage, but studies have shown inconsistent reporting of methods and challenges.

The review identified ten key methodological strategies to standardize HSAT procedures in research and practice, highlighting the need for consistent reporting to improve the reliability of HSAT studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methodological strategies in using home sleep apnea testing in research and practice. Miller, JN., Schulz, P., Pozehl, B., et al.[2019]

A single channel frontal EEG was validated against full EEG during polysomnography, showing a high agreement (92-95%) in scoring sleep versus wake, which suggests it could improve accuracy in sleep assessments.

In a study of 207 home sleep apnea tests (HSATs), the absence of EEG monitoring led to a 20% overestimation of sleep time and an 8% false-negative rate for obstructive sleep apnea (OSA) diagnoses, particularly affecting patients with insomnia or low sleep efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addition of frontal EEG to adult home sleep apnea testing: does a more accurate determination of sleep time make a difference? Light, MP., Casimire, TN., Chua, C., et al.[2020]

Home sleep apnea testing (HSAT) is a feasible and practical method for screening obstructive sleep apnea (OSA) in clinic patients with cognitive impairment, with 85.9% of those who attempted the test obtaining analyzable data.

The study involved 119 patients, of which 78 attempted HSAT, and 56.3% of all eligible patients provided analyzable data, indicating HSAT could help identify OSA, a modifiable risk factor for dementia, potentially leading to better cognitive health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of unattended home sleep apnea testing in a cognitively impaired clinic population. Colelli, DR., Black, SE., Masellis, M., et al.[2022]

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 study analyzing 838 diagnostic sleep tests, 26.4% of patients with obstructive sleep apnea (OSA) were found to be reclassified to a less severe category when the apnea-hypopnea index (AHI) was recalculated using time in bed instead of total sleep time, indicating a significant risk of underestimating OSA severity.

The risk of misclassification was particularly high among older patients, with 40.3% of moderate OSA cases and 36.0% of severe OSA cases being downgraded to milder categories, which could impact treatment decisions and patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential Underestimation of Sleep Apnea Severity by At-Home Kits: Rescoring In-Laboratory Polysomnography Without Sleep Staging. Bianchi, MT., Goparaju, B.[2018]

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 142 patients suspected of hypoventilation, awake oxygen saturation and arterial blood gas results were effective in predicting the failure of CPAP therapy, while home sleep apnea testing (HSAT) did not provide useful predictive value for nocturnal hypoxemia.

An awake oxygen saturation of 94% or higher could rule out CPAP failure, and a partial pressure of oxygen of 68 mmHg or more significantly reduced the likelihood of CPAP failure, highlighting the importance of these clinical parameters over HSAT in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting CPAP failure in patients with suspected sleep hypoventilation identified on ambulatory testing. Braganza, MV., Hanly, PJ., Fraser, KL., et al.[2021]

A modified definition of obstructive sleep apnea (OSA) that includes lower apnea-hypopnea indices (AHI 5-14.9) and oxygen desaturation (≤88%) led to a greater reduction in daytime sleepiness, as measured by the Epworth Sleepiness Scale, after starting CPAP treatment.

This modified definition did not negatively impact CPAP compliance rates or the accuracy of scoring sleep apnea, suggesting it could be a beneficial approach for patients with a history of stroke or transient ischemic attack.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Modified Definition for Obstructive Sleep Apnea in Home Sleep Apnea Testing after Stroke or Transient Ischemic Attack. Patel, N., Raissi, A., Elias, S., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7927336/

Feasibility of unattended home sleep apnea testing in a ... In conclusion, in a population of clinic patients with cognitive impairment, HSAT was a feasible and practical method to detect OSA, with patients' overall ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04335994

ENhancing Outcomes in Cognitive Impairment Through ... Our primary objective is to determine whether the use of HSAT is superior to iPSG in terms of the proportion of patients who complete sleep testing by 6 months ...

3. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-025-07244-x

Relationship between sleep apnea severity and mild cognitive ... The sleep apnea severity assessed by ODI was positively related to mild cognitive impairment. In addition, there was a positive relation between ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12537604/

Prevalence of cognitive impairment among adults with ... Across 23 studies involving 33,226 individuals, the pooled prevalence of cognitive impairment among adult OSA patients was 36.92% (95% CI: 26.62 ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1551714423003476

REducing Sleep Apnoea for the PrEvention of Dementia ... A full-scale trial investigating the effects of treating OSA on cognitive decline in older adults at risk of dementia within memory clinic settings.

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/235330

ENhancing Outcomes in Cognitive Impairment Through ... A convenient and cheaper alternative to iPSG is home sleep apnea testing (HSAT), which has been validated against iPSG to diagnose OSA and has ...

7. academic.oup.com academic.oup.com/sleep/article/48/Supplement_1/A276/8136091

0633 A Comparison of Home Sleep Apnea Testing Ordered ... This study compared performance metrics and OSA diagnosis for PCP and specialists utilizing home sleep apnea testing (HSAT).