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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if using CPAP (a machine that aids nighttime breathing) along with online sleep education can improve memory and thinking in older adults with mild cognitive issues and untreated obstructive sleep apnea (a condition where breathing stops and starts during sleep). Participants are divided into two groups: one starts CPAP immediately, while the other begins after four months of sleep education, to assess if earlier CPAP initiation is more beneficial. This study targets adults over 55 with mild cognitive impairment and moderate to severe sleep apnea who have not received prior apnea treatment. As an unphased trial, it offers a unique opportunity to contribute to understanding how sleep treatments can enhance cognitive health.

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 prior data suggests that CPAP therapy is safe for older adults with mild cognitive impairment and obstructive sleep apnea?

Research has shown that CPAP (Continuous Positive Airway Pressure) therapy is generally safe for individuals with obstructive sleep apnea (OSA). Studies indicate that CPAP use can enhance quality of life and reduce health risks associated with sleep apnea. For instance, one study found that regular CPAP use decreased excessive sleepiness and improved mental sharpness. Another study demonstrated that CPAP users had a lower risk of serious heart problems and even reduced death rates.

Regarding side effects, CPAP is usually well-tolerated. Some users might experience minor issues like a stuffy nose or discomfort from the mask, but these can often be managed by adjusting the equipment or settings.

CPAP is already widely used to treat sleep apnea, which supports its safety for this trial. Overall, evidence suggests that CPAP is a safe option with benefits that outweigh potential risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CPAP therapy trial for obstructive sleep apnea because it integrates personalized support and web-based sleep education, which sets it apart from conventional treatments. Traditional CPAP therapy often lacks the continuous, personalized guidance provided in this trial, where participants receive structured support from sleep technologists through calls and video sessions. Additionally, the inclusion of the Brain Health Pro platform offers a unique educational component aimed at increasing dementia awareness and promoting lifestyle changes to reduce dementia risk, a feature not typically included in standard sleep apnea treatments. This comprehensive approach not only targets sleep apnea but also addresses broader health concerns, making it a promising advancement over existing options.

What evidence suggests that CPAP therapy and web-based sleep education could be effective for improving cognitive function in older adults with mild cognitive impairment and obstructive sleep apnea?

Research has shown that CPAP (Continuous Positive Airway Pressure) therapy effectively treats obstructive sleep apnea (OSA). Studies have found that regular CPAP use significantly reduces symptoms like interrupted breathing during sleep and improves the quality of life for individuals with moderate to severe OSA. Additionally, regular CPAP use is linked to a lower risk of death and heart problems. Observational studies suggest that using CPAP for at least four hours each night reduces the risk of death compared to not using it. In this trial, participants in the Early CPAP group will receive a CPAP device at their baseline visit, while those in the Later CPAP group will receive the device after an initial period of web-based sleep education. These findings support the idea that CPAP can enhance sleep and overall health. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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

Non-resident of Ontario

Contraindications to MRI

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5436801/

IMPACT OF CONTINOUS POSITIVE AIRWAY PRESSURE ... We found that long-term improvement in quality of life occurs with the use of CPAP in persons with severe and possibly moderate sleep apnea.

2. cjrt.ca cjrt.ca/article/92080-positive-airway-pressure-therapy-adherence-and-outcomes-in-obstructive-sleep-apnea-an-exploratory-longitudinal-retrospective-randomized-chart-review

Positive airway pressure therapy adherence and outcomes ... Observational studies have found a significant reduction in mortality with four or more hours per night of PAP therapy compared to no usage9–12; ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2212534524000790

Assessment and management of continuous positive ... CPAP is a highly effective treatment for OSA and is supported by extensive evidence of its efficacy in reducing apneas, alleviating symptoms, and addressing ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2823539

Positive Airway Pressure, Mortality, and CV Risk in Older ... In this cohort study of Medicare beneficiaries with OSA, PAP utilization was associated with lower all-cause mortality and MACE incidence.

5. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.10740

Effects of continuous positive airway pressure on cardiac ... Conclusions: CPAP therapy might prevent subsequent MACEs and all-cause death among patients with moderate to severe obstructive sleep apnea and concomitant ...

6. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.10832

Long-term health outcomes for patients with obstructive sleep ... These authors reported a risk ratio of 0.43 (95% confidence interval: 0.30–0.63) for MVCs following CPAP therapy, similar to the overall point estimate. These ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1389945724001096

Real-world impact of continuous positive airway pressure ... After starting CPAP treatment, the overall median (IQR) ESS score decreased (improved) by 2 (6) points from baseline to follow-up, and mean ESS scores decreased ...

8. cms.gov cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&NCAId=204

Continuous Positive Airway Pressure (CPAP) Therapy for ... For patients with severe OSA, nasal CPAP is the treatment of choice. Its regular use improves excessive sleepiness, cognitive performance, and quality of life ( ...