CPAP for Mild Cognitive Impairment Due to Sleep Apnea

(MCI:OSA Trial)

Recruiting at 3 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

327 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this project is to determine whether obstructive sleep apnea (OSA) treatment with positive airway pressure therapy (CPAP) can delay the progression of cognitive impairment in patients with amnestic Mild Cognitive Impairment (MCI) as measured by cognitive testing, and brain magnetic resonance imaging (MRI) scans. Study participants will be assessed at baseline, six-month (cognitive tests only) and one-year follow-up.

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.

Is CPAP generally safe for humans?

CPAP (Continuous Positive Airway Pressure) is generally considered safe for humans, as it is a common treatment for sleep apnea and has been used widely without significant safety concerns. While specific safety data for CPAP in treating mild cognitive impairment due to sleep apnea is limited, its long-standing use in other conditions suggests it is safe for human use. ^{1 2 3 4 5}

How does CPAP treatment differ from other treatments for mild cognitive impairment due to sleep apnea?

CPAP (Continuous Positive Airway Pressure) is unique because it directly addresses obstructive sleep apnea (OSA) by keeping the airway open during sleep, which may help delay cognitive decline in patients with mild cognitive impairment. Unlike medications, CPAP is a non-drug treatment that requires wearing a mask connected to a machine while sleeping. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment CPAP for Mild Cognitive Impairment Due to Sleep Apnea?

Research suggests that using CPAP (a machine that helps keep your airway open while you sleep) may slow down cognitive decline in people with mild cognitive impairment and sleep apnea. Studies have shown improvements in memory and everyday function with CPAP use, although more research is needed to confirm these benefits. ^{6 7 8 11 12}

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

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]

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]

Citations

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

Use of positive airway pressure in mild cognitive impairment to delay progression to dementia. [2021]

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

CPAP Adherence May Slow 1-Year Cognitive Decline in Older Adults with Mild Cognitive Impairment and Apnea. [2020]

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

Predictors of Adherence to Continuous Positive Airway Pressure in Older Adults With Apnea and Amnestic Mild Cognitive Impairment. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Positive airway pressure adherence among patients with obstructive sleep apnea and cognitive impairment: A narrative review. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

Obstructive sleep apnea syndrome and Alzheimer's disease pathology: may continuous positive airway pressure treatment delay cognitive deterioration? [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Characterization of respiratory compromise and the potential clinical utility of capnography in the post-anesthesia care unit: a blinded observational trial. [2021]

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

Safety-Related Drug Label Changes Following Large Post-Marketing Cardiometabolic Trials: A Review of European Public Assessment Reports. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Minimum dataset for endolaryngeal surgery: pilot study. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Monitoring product safety in the postmarketing environment. [2021]

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

Dealing with a deluge of data: an assessment of adverse event data on North Central Cancer Treatment Group trials. [2007]

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

Effects of continuous positive airway pressure on neurocognitive function in obstructive sleep apnea patients: The Apnea Positive Pressure Long-term Efficacy Study (APPLES). [2022]

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

One Year of Continuous Positive Airway Pressure Adherence Improves Cognition in Older Adults With Mild Apnea and Mild Cognitive Impairment. [2021]