CPAP Therapy for Obstructive Sleep Apnea

Overseen By Sara Mitchell, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Must not be taking: Disease modifying agents

Disqualifiers: Driving accidents, Insomnia, Restless legs, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 months

206 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it does exclude those taking disease-modifying agents for mild cognitive impairment.

What data supports the effectiveness of CPAP Therapy and Web-Based Sleep Education for treating obstructive sleep apnea?

Research shows that using an interactive website designed for sleep apnea patients can improve adherence to CPAP therapy, meaning patients are more likely to use the treatment as recommended. This increased adherence can lead to better outcomes for those with obstructive sleep apnea. ^{1 2 3 4 5}

Is CPAP therapy safe for humans?

CPAP therapy is generally considered safe for humans, but some patients may experience side effects like discomfort, nasal congestion, or dry mouth. It's important to discuss any concerns with a healthcare provider to ensure proper use and address any issues. ^{1 5 6 7 8}

How does CPAP therapy with web-based sleep education differ from other treatments for obstructive sleep apnea?

CPAP therapy is the most effective treatment for obstructive sleep apnea, but adherence is often poor. This trial includes web-based sleep education, which aims to improve adherence by providing patients with better understanding and management of their condition through online resources. ^{1 2 8 9 10}

What is the purpose of this trial?

The overall goal of this randomized controlled trial is to test the hypothesis that in older adults with mild cognitive impairment (MCI) and previously untreated obstructive sleep apnea (OSA), 4 months of web-based sleep education and continuous positive airway pressure (CPAP) will improve cognitive function more than web-based sleep education alone. Secondarily, this trial will test the hypothesis that 8 months of CPAP will improve cognitive function more than 4 months of CPAP. Moreover, treating OSA with CPAP can improve cognitive function and reduce Alzheimer's disease-related brain changes in older adults with MCI. This study will compare an Early CPAP Group who will receive CPAP and sleep education simultaneously for 8 months upon enrollment to a Later CPAP Group who will first receive sleep education for 4 months followed by CPAP and sleep education for the next 4 months to test if early treatment is more beneficial. Participants will: 1. Complete web-based sleep education modules through the Brain Health Pro (BHP) platform 2. Undergo CPAP therapy, including in-person mask fitting and regular monitoring alongside a study sleep technologist At 0 months, 4 months, and 8 months, participants will participate in cognitive assessments, provide blood samples, use wearable devices to measure sleep patterns and physiology, and complete a 1-hr MRI (0 months and 4 months only).

Eligibility Criteria

This trial is for older adults with mild cognitive impairment (MCI) and untreated obstructive sleep apnea (OSA). Participants will engage in web-based sleep education and undergo CPAP therapy to see if it improves cognitive function. The study excludes details on specific inclusion or exclusion criteria.

Inclusion Criteria

MCI: Participants meeting specific criteria for Mild Cognitive Impairment (MCI) based on MoCA, Logical Memory II, and Lawton-Brody Instrumental Activities of Daily Living Scale Score

I have moderate to severe obstructive sleep apnea confirmed by tests.

Informed consent obtained and signed

Exclusion Criteria

Contraindications to MRI

Non-resident of Ontario

I cannot use CPAP or am not willing to start CPAP therapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CPAP therapy and web-based sleep education for 8 months in the Early CPAP group or 4 months of sleep education followed by 4 months of CPAP and sleep education in the Later CPAP group

8 months

Regular in-person and virtual visits for CPAP monitoring and support

Cognitive Assessment

Participants undergo cognitive assessments, provide blood samples, use wearable devices to measure sleep patterns and physiology, and complete MRI scans

8 months

Assessments at 0, 4, and 8 months; MRI at 0 and 4 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• CPAP Therapy
• Web-Based Sleep Education

Trial Overview The study tests whether CPAP combined with web-based sleep education can improve cognition in MCI patients more than just the education alone. It also examines if longer treatment duration (8 months vs. 4 months of CPAP) has additional benefits.

Participant Groups

Group I: Group 1 (Early CPAP group) Experimental Treatment 1 Intervention

Participant will receive a study-provided CPAP device at their baseline visit, with settings set by one of the study sleep medicine physicians according to current clinical practice parameters. Participant will undergo an in-person mask fitting and then will be supported by a study sleep technologist with extensive clinical experience with CPAP who will contact the participant by telephone or video call at set intervals. Masks, tubing, chin straps, and other equipment necessary to optimize CPAP adherence will be provided by the study. Adherence will be monitored through downloads from the CPAP device. Participant will be asked to use CPAP nightly during their participation in this study. Participant will simultaneously participate in web-based sleep education through the Brain Health Pro (BHP) platform; a formal educational program designed to increase dementia literacy, foster engagement, and convey best available evidence for lifestyle changes that can mitigate dementia risk.

Group II: Group 2 (Later CPAP group) Active Control 1 Intervention

Participant will receive the web-based sleep educational intervention first for 4 months. Participant will then receive a study-supplied CPAP device with settings set by one of the study sleep medicine physicians according to current clinical practice parameters. Participant will undergo an in-person mask fitting and will be supported by a study sleep technologist with extensive clinical experience with CPAP who will contact the participant by telephone or video call at set intervals. Equipment necessary to optimize CPAP adherence will be provided. Adherence will be monitored through downloads from the CPAP device. Participant will be asked to use CPAP nightly throughout their participation. Participant will simultaneously participate in web-based sleep education through the Brain Health Pro platform; a formal educational program designed to increase dementia literacy, foster engagement and convey best available evidence for lifestyle changes that can mitigate dementia risk.

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Baycrest

Collaborator

Trials

46

Recruited

6,900+

University Health Network, Toronto

Collaborator

Trials

1,555

Recruited

526,000+

Centre for Addiction and Mental Health

Collaborator

Trials

388

Recruited

84,200+

Findings from Research

eHealth interventions significantly improve CPAP adherence among adults with obstructive sleep apnea, increasing average nightly use by about 0.54 hours compared to usual care, based on a meta-analysis of 18 studies involving 5429 participants.

The effectiveness of eHealth strategies appears consistent regardless of whether they are used as an add-on to traditional care or as standalone solutions, but there is still uncertainty about the best types and durations of these interventions for long-term adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of eHealth Interventions in Improving Treatment Adherence for Adults With Obstructive Sleep Apnea: Meta-Analytic Review. Aardoom, JJ., Loheide-Niesmann, L., Ossebaard, HC., et al.[2020]

A randomized controlled trial involving 120 newly diagnosed sleep apnea patients found that video instruction for using CPAP machines is as effective as traditional in-person instruction by a nurse, with no significant differences in outcomes between the two methods.

The study suggests that video instruction is a feasible alternative to physical attendance for CPAP start-up, potentially saving time for both healthcare workers and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-person versus video instruction of patients with sleep apnoea in the use of continuous positive airway pressure (CPAP). Fuglsang, M., Duez, C., Dahl, LB., et al.[2022]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Effectiveness of eHealth Interventions in Improving Treatment Adherence for Adults With Obstructive Sleep Apnea: Meta-Analytic Review. [2020]

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

Polysomnograph chart view by patients: a new educational strategy to improve CPAP adherence in sleep apnea therapy. [2014]

3. Egypt pubmed.ncbi.nlm.nih.gov

Patient perspective on use of an interactive website for sleep apnea. [2022]

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

Patient data access and online sleep apnea communities. [2011]

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

Effects of augmented continuous positive airway pressure education and support on compliance and outcome in a Chinese population. [2019]

6. Denmark pubmed.ncbi.nlm.nih.gov

In-person versus video instruction of patients with sleep apnoea in the use of continuous positive airway pressure (CPAP). [2022]

7. Ireland pubmed.ncbi.nlm.nih.gov

Perceived informational needs, side-effects and their consequences on adherence - a comparison between CPAP treated patients with OSAS and healthcare personnel. [2015]

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

Accuracy and Reliability of Internet Resources Providing Information on Obstructive Sleep Apnea. [2019]

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

Tolerance and intolerance to continuous positive airway pressure. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Adherence to continuous positive airway pressure therapy in obstructive sleep apnea syndrome: effect of visual education. [2021]