Home Sleep Apnea Testing for Cognitive Impairment

(ENCHANT Trial)

Overseen By Mark I Boulos, MD, MSc

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Sunnybrook Health Sciences Centre

Disqualifiers: Prior OSA diagnosis, CPAP use, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

Obstructive sleep apnea (OSA), which causes abnormal pauses in breathing during sleep, is common in patients with vascular cognitive impairment (VCI) and Alzheimer's disease (AD), and exacerbates the cognitive deficits seen in these conditions. OSA is typically treated with continuous positive airway pressure (CPAP), which has been shown to improve cognition in VCI and slow cognitive decline in AD. Despite the need to identify OSA in patients with VCI/AD, these patients often do not undergo testing for OSA. One major barrier is that in-laboratory polysomnography (iPSG), the current standard for diagnosing OSA, is inconvenient for patients with VCI/AD who may be reliant on others for care or require familiar sleep environments. A convenient and cheaper alternative to iPSG is home sleep apnea testing (HSAT), which has been validated against iPSG to diagnose OSA and has proven feasible for use in VCI/AD. 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 post-randomization. We will also investigate cost-effectiveness, patient satisfaction, proportion of patients treated with CPAP, changes in cognition, mood, sleep-related and functional outcomes between HSAT and iPSG at 6 months.

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 data supports the effectiveness of the treatment Home Sleep Apnea Test for cognitive impairment?

Home sleep apnea testing (HSAT) is a validated method to screen for obstructive sleep apnea (OSA), which is linked to an increased risk of developing dementia. While HSAT is convenient for diagnosing OSA in cognitively well individuals, its feasibility in patients with cognitive impairment is still being evaluated. ^{1 2 3 4 5}

Is home sleep apnea testing safe for humans?

Home sleep apnea testing (HSAT) is generally considered safe for humans as it is a non-invasive method used to diagnose sleep apnea. It is widely used and validated for screening obstructive sleep apnea, even though it may not always capture the full severity of the condition compared to in-laboratory tests. ^{1 2 3 6 7}

How is the Home Sleep Apnea Test (HSAT) treatment different from other treatments for cognitive impairment?

The Home Sleep Apnea Test (HSAT) is unique because it allows for convenient, at-home screening for obstructive sleep apnea (OSA), which is linked to cognitive impairment. Unlike traditional sleep studies that require overnight stays in a lab, HSAT can be done at home, making it more accessible and less disruptive for patients. ^{1 2 3 7 8}

Research Team

Mark I Boulos, MD, MSc

Principal Investigator

University of Toronto and Sunnybrook Health Sciences Centre

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Home Sleep Apnea Test (Procedure)
• In-laboratory polysomnography (Procedure)

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.

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: Standard of Care Active Control 1 Intervention

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

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+

Findings from Research

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]

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 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 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]

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]

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]

References

1. 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]

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

Feasibility of unattended home sleep apnea testing in a cognitively impaired clinic population. [2022]

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

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

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

Predicting CPAP failure in patients with suspected sleep hypoventilation identified on ambulatory testing. [2021]

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

A Modified Definition for Obstructive Sleep Apnea in Home Sleep Apnea Testing after Stroke or Transient Ischemic Attack. [2018]

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

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

7. Germany pubmed.ncbi.nlm.nih.gov

Methodological strategies in using home sleep apnea testing in research and practice. [2019]

8. Germany 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? [2020]