CPAP for Mild Cognitive Impairment Due to Sleep Apnea

(MCI:OSA Trial)

Not currently recruiting at 4 trial locations

Overseen By Jennifer Morris, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Neurologic disease, Psychiatric disorders, Alcohol abuse, others

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

Compensation: Varies

Number of Visits: 6

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether using a CPAP machine, which keeps airways open during sleep, can slow memory problems in people with mild cognitive issues due to sleep apnea. Participants will be divided into groups: those who use the CPAP regularly, those who don't, and those without sleep apnea. The trial aims to determine if regular CPAP use can improve memory and brain health over time. It suits individuals with sleep apnea and mild memory problems who can consistently use a CPAP machine. As an unphased trial, this study offers a unique opportunity to contribute to understanding how CPAP use might benefit memory and brain health.

Will I have to stop taking my current medications?

The trial requires that your current medications, like antidepressants, be stable for at least 4 weeks, and cholinesterase inhibitors or memantine be stable for 12 weeks before joining. So, you won't have to stop them, but they need to be stable for a certain period.

What prior data suggests that CPAP is safe for treating sleep apnea?

Research has shown that CPAP (Continuous Positive Airway Pressure) therapy is generally easy for people with sleep apnea to use. One study found that long-term CPAP use improves the quality of life for those with severe or moderate sleep apnea, indicating the treatment's safety for regular use. Another study found that patients using CPAP had normal levels of certain proteins linked to Alzheimer's disease, suggesting CPAP might help protect the brain over time.

Overall, CPAP is widely used and has a strong safety record. Most people adapt to the treatment without serious side effects. However, as with any treatment, individual experiences can vary, so discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using CPAP (Continuous Positive Airway Pressure) for mild cognitive impairment due to sleep apnea because it directly tackles the root cause—obstructive sleep apnea (OSA)—which is not the primary focus of most cognitive impairment treatments. While typical treatments for cognitive issues might include medications or cognitive therapies aimed at symptom management, CPAP targets the underlying sleep disorder, potentially improving both sleep quality and cognitive function. By consistently using CPAP, patients may experience better oxygen flow during sleep, which can positively impact brain health and cognitive performance, offering a dual benefit not commonly addressed by standard cognitive treatments.

What evidence suggests that CPAP is effective for delaying cognitive impairment in patients with sleep apnea?

Studies have shown that CPAP (Continuous Positive Airway Pressure) can improve memory and learning in people with obstructive sleep apnea (OSA). Research suggests that regular CPAP use for a year enhances overall brain function. However, other studies found that CPAP might not prevent dementia in individuals with mild cognitive impairment (MCI) and OSA. This trial will divide participants into groups: CPAP adherent, CPAP non-adherent, and those without OSA. While some results are promising, evidence on CPAP's ability to prevent memory and thinking problems remains mixed. Participants should consider these findings and discuss them with healthcare providers. ^{1 4 6 7 8}

Who Is on the Research Team?

Nalaka Gooneratne, MD, MSc

Principal Investigator

Associate Professor

Kathy Richards, PhD

Principal Investigator

Professor

David Wolk, MD

Principal Investigator

Associate Professor

Are You a Good Fit for This Trial?

This trial is for adults aged 55-85 with mild cognitive impairment and moderate to severe obstructive sleep apnea, who are not depressed or suffering from significant neurological diseases other than amnestic MCI. Participants must have stable medication use, a study partner, be fluent in English or Spanish, and able to complete the study's requirements.

Inclusion Criteria

Completed at least 6 grades of education

If you scored between 28 and 35 on the optional cognitive test over the phone.

You have a low score on a test for depression called the Geriatric Depression Scale.

Exclusion Criteria

I have used a CPAP or BiPAP machine regularly for my sleep apnea in the last 6 months.

I have not had a brain tumor, seizure, bleeding in the brain, or stroke in the last 6 months.

I do not have any serious illnesses that would make following the study rules hard for me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CPAP treatment for obstructive sleep apnea to assess its impact on cognitive impairment

12 months

Baseline, 6-month (cognitive tests only), and 1-year follow-up

Follow-up

Participants are monitored for safety and effectiveness after treatment, including cognitive testing and brain MRI scans

1 year

What Are the Treatments Tested in This Trial?

Interventions

• CPAP

Trial Overview The trial is testing if using CPAP therapy can slow down cognitive decline in patients with memory issues due to amnestic Mild Cognitive Impairment. It involves baseline assessments, follow-ups at six months (cognitive tests only), and one year with both cognitive tests and brain MRI scans.

How Is the Trial Designed?

Group I: CPAP adherent Experimental Treatment 1 Intervention

Study participants in this arm are using the CPAP intervention consistently

Group II: No OSA Active Control 1 Intervention

Study participants who do not have OSA

Group III: CPAP non-adherent Active Control 1 Intervention

Study participants in this arm are not using the CPAP intervention consistently

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

In a review of 26 cancer treatment trials involving 75,598 routine adverse events (RAEs), only 3% were severe or life-threatening, indicating that most RAEs collected are not clinically significant.

The study suggests that 72% of RAEs could be eliminated from monitoring without compromising patient safety or the evaluation of treatment regimens, highlighting the potential for more efficient data collection in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dealing with a deluge of data: an assessment of adverse event data on North Central Cancer Treatment Group trials. Mahoney, MR., Sargent, DJ., O'Connell, MJ., et al.[2007]

A study of 55 large clinical trials involving over 402,000 patients found that 69% resulted in updates to the safety information on drug labels for cardiometabolic agents, indicating that these trials can provide valuable safety data post-approval.

However, the overall contribution of these trials to new safety information was limited, with only 35% leading to changes in adverse drug reactions, suggesting that selective safety data collection may not significantly enhance safety knowledge for drugs already studied extensively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety-Related Drug Label Changes Following Large Post-Marketing Cardiometabolic Trials: A Review of European Public Assessment Reports. Starokozhko, V., Tarrahi, F., Vrijlandt, PJWS., et al.[2023]

The safety profile of medications can change after they are approved for public use, as new safety issues may arise that were not identified during clinical trials.

Regulatory agencies, like the FDA, actively monitor medication safety through various methods, including analyzing adverse experience reports and using large electronic databases to detect potential safety signals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring product safety in the postmarketing environment. Sharrar, RG., Dieck, GS.[2021]

Citations

1. atsjournals.org atsjournals.org/doi/full/10.1164/rccm.202111-2646LE

A Pilot Randomized Crossover Clinical Trial CPAP was, however, associated with medium effect size improvements in verbal learning and memory retention compared with no treatment (Table 2). There was no ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10222823/

Impact of CPAP Therapy Adherence on Global Cognition in ... Conclusions: One year of CPAP adherence improved global cognition associated with OSA. Keywords: cognition, obstructive sleep apnea, continuous ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01482351

Mild Cognitive Impairment and Obstructive Sleep Apnea Device: Continuous Positive Airway Pressure (CPAP). This arm included those diagnosed with mild cognitive impairment (MCI) and obstructive sleep apnea (OSA).

4. sciencedirect.com sciencedirect.com/science/article/pii/S1087079223001259

A systematic review on adherence to continuous positive ... Previous reviews conducted on CPAP adherence demonstrated non-adherence rates, based on 7 h/night sleep time across 82 papers, to be 34.1% [24]. However, these ...

5. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.8346

Use of positive airway pressure in mild cognitive impairment to ... In our retrospective chart review study, CPAP use in patients with MCI and OSA was not associated with delay in progression to dementia or cognitive decline.

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/study/NCT01482351

Mild Cognitive Impairment and Obstructive Sleep Apnea ... Obstructive sleep apnea (OSA) has been linked to increased risk for Alzheimer's disease (AD), but little prospective evidence exists on the effects of OSA ...

7. 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.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6943882/

Obstructive Sleep Apnea and the Risk of Cognitive Decline in ... In that study, patients with OSA treated with continuous positive airway pressure (CPAP) had normal Aβ42 and total tau/Aβ42 ratio levels. These CSF findings ...