CPAP Therapy for Alzheimer's Disease

Recruiting at 1 trial location

Overseen By Pam DeYoung

Age: 65+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of California, San Diego

Disqualifiers: Smoking, COPD, Heart failure, Neuromuscular disease, others

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

260 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how treating obstructive sleep apnea (OSA) might influence Alzheimer's disease. People with OSA often experience breathing interruptions during sleep, which can affect memory and brain health. The trial will test two treatments: supplemental oxygen and CPAP therapy (Continuous Positive Airway Pressure therapy), comparing them to regular room air. It targets individuals aged 65-85 who live independently, can drive, and either have OSA or do not. Participants should not have conditions like asthma or heart failure and must be able to complete study activities in English. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that CPAP therapy, which aids breathing during sleep, is generally safe for most people. Studies have found that it can improve sleep quality and reduce daytime tiredness in individuals with Alzheimer's disease. Most people tolerate CPAP well, and it quickly normalizes breathing in many cases.

Many studies suggest that supplemental oxygen treatment is a safe and effective option. Oxygen therapy has been shown to help with Alzheimer's symptoms and improve related health risks, indicating that patients usually tolerate it well.

Both treatments have been tested in various settings and have demonstrated positive safety results. For any concerns or questions, consulting a healthcare provider is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using CPAP therapy for Alzheimer's disease because it explores a new approach by addressing sleep disturbances, specifically obstructive sleep apnea (OSA), which may influence cognitive function. Traditional treatments for Alzheimer's primarily target amyloid plaques or neurotransmitter levels in the brain. In contrast, CPAP therapy focuses on improving sleep quality and oxygenation, which could have downstream benefits on cognitive health. This trial is investigating if enhancing sleep through CPAP could slow cognitive decline, offering a fresh angle compared to existing therapies.

What evidence suggests that this trial's treatments could be effective for Alzheimer's disease?

Research shows that using a CPAP machine, one of the treatments in this trial, can help people with Alzheimer's disease and sleep apnea sleep better. Studies have found that CPAP use leads to deeper sleep, which is important because poor sleep can worsen memory problems. Regular CPAP use also slows memory and thinking problems in people with Alzheimer's.

Regarding oxygen therapy, another treatment option in this trial, research suggests it might improve brain function and health. Clinical studies have shown that oxygen therapy can boost brain activity and may help with Alzheimer's symptoms. Both treatments are promising for managing sleep apnea and possibly slowing Alzheimer's progression. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for men and women aged 65-85 who live independently, can drive, have a MOCA score over 26, and either have obstructive sleep apnea (AHI ≥ 15/h) or do not. They must be non-smokers without neuromuscular disease, COPD, asthma, severe heart issues or uncontrolled hypertension. Participants cannot have contraindications to MRI scans.

Inclusion Criteria

You score more than 26 on the MOCA test.

I live on my own and can drive.

Subjects must consent to waiving their right to obtain their PHS score (since the score is not yet actionable and could lead to social stress and ethical dilemmas)

Exclusion Criteria

I have a brain tumor or have had a significant stroke.

I have a history of COPD or asthma.

I am unable to complete English-only study materials.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either supplemental oxygen or PAP therapy for OSA over a 12-week period, with weekly adherence monitoring

12 weeks

Weekly remote monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including neuroimaging and sleep assessments

4 weeks

Neuroimaging

MRI and PET scans to assess brain structure and function in relation to OSA and AD risk

2 hours

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Continuous Positive Airway Pressure Machine
• Room Air
• Supplemental Oxygen

Trial Overview The study investigates the impact of obstructive sleep apnea on Alzheimer's progression by comparing three interventions: room air (normal breathing), use of a CPAP machine to assist with breathing during sleep, and supplemental oxygen therapy.

How Is the Trial Designed?

Group I: Supplemental Oxygen for 3 Months Experimental Treatment 1 Intervention

Over a 12-week period, participants randomized to receive supplemental Oxygen for treatment of OSA will be contacted weekly to be asked about their adherence. Participants' adherence will also be monitored remotely through cloud-based monitoring.

Group II: PAP Therapy for 3 Months Experimental Treatment 1 Intervention

Over a 12-week period, participants randomized to receive supplemental PAP therapy for treatment of OSA will be contacted weekly to be asked about their adherence. Participants' adherence will also be monitored remotely through cloud-based monitoring.

Group III: Supplemental Oxygen during PSG Active Control 1 Intervention

Subjects will be instrumented with a nasal cannula to receive 2L/min supplemental oxygen. The oxygen will be kept at a fixed rate, however, the participant will be titrated to receive a max of 4 liters per min to maintain sats \>90% based on oximetry readings.

Group IV: Room Air during PSG Placebo Group 1 Intervention

Subjects will be instrumented with a nasal cannula to receive 2L/min of pressurized room air. The room air will be kept at a fixed rate, however, the participant will be titrated to receive a max of 4 liters per min to maintain sats \>90% based on oximetry readings.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Published Research Related to This Trial

In a randomized trial involving 39 elderly patients with mild to moderate Alzheimer's disease and sleep-disordered breathing, therapeutic CPAP significantly reduced daytime sleepiness, as measured by the Epworth Sleepiness Scale, from an average score of 8.89 to 5.53 after 6 weeks of treatment.

The study demonstrated that CPAP treatment is effective in improving daytime alertness in Alzheimer's patients with sleep-disordered breathing, highlighting its potential as a beneficial intervention for enhancing quality of life in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous positive airway pressure reduces subjective daytime sleepiness in patients with mild to moderate Alzheimer's disease with sleep disordered breathing. Chong, MS., Ayalon, L., Marler, M., et al.[2008]

Patients with Alzheimer's disease (AD) can tolerate continuous positive airway pressure (CPAP) therapy for obstructive sleep apnea, wearing it for an average of 4.8 hours per night.

Those who continued using CPAP reported fewer depressive symptoms and better adherence, suggesting that managing depression may improve long-term use of CPAP in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to continuous positive airway pressure treatment in patients with Alzheimer's disease and obstructive sleep apnea. Ayalon, L., Ancoli-Israel, S., Stepnowsky, C., et al.[2017]

The LeVe CPAP system, designed using frugal innovation principles, provides an effective and low-complexity solution for delivering non-invasive ventilation, achieving target pressure levels comparable to existing systems while being resource-efficient.

In a pilot study with ten healthy volunteers, the LeVe system was found to be safe and well-tolerated, with no adverse events, indicating its potential for use in resource-limited settings during the COVID-19 pandemic and for other respiratory conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The LeVe CPAP System for Oxygen-Efficient CPAP Respiratory Support: Development and Pilot Evaluation. Culmer, P., Davis Birch, W., Waters, I., et al.[2023]

Sustained use of continuous positive airway pressure (CPAP) for an average of 13.3 months in patients with Alzheimer's disease (AD) and obstructive sleep apnea (OSA) showed moderate-to-large improvements in cognitive function, mood stabilization, and sleep quality compared to those who discontinued CPAP.

Caregivers of patients using CPAP reported better sleep and observed improvements in their patients' behavior, suggesting that long-term CPAP treatment may benefit both patients and caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained use of CPAP slows deterioration of cognition, sleep, and mood in patients with Alzheimer's disease and obstructive sleep apnea: a preliminary study. Cooke, JR., Ayalon, L., Palmer, BW., et al.[2022]

In a study involving 52 patients with mild to moderate Alzheimer's disease and obstructive sleep apnea, treatment with continuous positive airway pressure (CPAP) for 6 weeks showed significant improvements in cognitive function after 3 weeks of therapy, particularly in verbal learning and memory.

The findings suggest that obstructive sleep apnea may worsen cognitive decline in Alzheimer's patients, and treating OSA with CPAP could potentially reverse some cognitive impairments, highlighting the importance of addressing sleep apnea in dementia care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive effects of treating obstructive sleep apnea in Alzheimer's disease: a randomized controlled study. Ancoli-Israel, S., Palmer, BW., Cooke, JR., et al.[2022]

Continuous positive airway pressure (CPAP) treatment for patients with Alzheimer's disease (AD) and obstructive sleep apnea (OSA) significantly reduces excessive daytime sleepiness and improves sleep quality, based on a systematic review of 5 studies including 3 randomized controlled trials.

There is evidence suggesting that CPAP may help stabilize cognitive function in Alzheimer's patients, as indicated by improvements in Mini Mental Scale scores, although further research is necessary to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Positive Airway Pressure Treatment in Patients with Alzheimer's Disease: A Systematic Review. Perez-Cabezas, V., Ruiz-Molinero, C., Jimenez-Rejano, JJ., et al.[2020]

In a study of 52 Alzheimer's disease patients with obstructive sleep apnea, continuous positive airway pressure (CPAP) therapy significantly improved sleep quality after just one night, leading to less light sleep and more deep sleep.

After 3 weeks of therapeutic CPAP, participants experienced reduced wake time after sleep onset and fewer arousals, indicating sustained improvements in sleep parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous positive airway pressure deepens sleep in patients with Alzheimer's disease and obstructive sleep apnea. Cooke, JR., Ancoli-Israel, S., Liu, L., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2783482/

Continuous positive airway pressure deepens sleep in ... In mild to moderate AD patients with OSA, the use of tCPAP resulted in deeper sleep after just one night, with improvements maintained for three weeks.

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

A systematic review on adherence to continuous positive ... Overall, the presence of sleep-disordered breathing (SDB) is associated with an increased risk of developing cognitive impairment by 26–35%, and slight ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2725246/

Sustained Use of CPAP Slows Deterioration of Cognition ... Continuous positive airway pressure (CPAP) has recently been shown to have beneficial effects on cognition in AD. Little attention has focused on the long-term ...

4. neurology.org neurology.org/doi/10.1212/WNL.0000000000213955

Continuous Positive Airway Pressure and Progression of ... If confirmed in randomized controlled trials, this suggests that CPAP, a widely used, clinically available, effective, and noninvasive treatment ...

5. reports.mountsinai.org reports.mountsinai.org/article/pulm2023-06-sleep-apnea-and-alzheimers-disease

Brief Withdrawal of Apnea Therapy Could Increase ... Read about Mount Sinai's discovery that a brief withdrawal of PAP apnea therapy could increase Alzheimer's risk.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7019587/

Continuous Positive Airway Pressure Treatment in Patients ... Conclusions: CPAP treatment in AD patients decreases excessive daytime sleepiness and improves sleep quality. There are indications that ...

7. movementdisorders.onlinelibrary.wiley.com movementdisorders.onlinelibrary.wiley.com/doi/10.1002/mds.29993

Immediate Effect of Continuous Positive Airway Pressure ... It showed immediate benefits in most cases, including normalization of respiratory measures in 60% of patients, lower arousal index, and ...

8. mdpi.com mdpi.com/2075-1729/13/3/613

Continuous Positive Airway Pressure Reduces Plasma ... A review study summarized the outcomes of clinical and animal studies and indicated that OSA may causally affect the incidence of Alzheimer's disease (AD) [4].

9. atsjournals.org atsjournals.org/doi/full/10.1513/AnnalsATS.202303-258ST

Annals of the American Thoracic Society High-quality evidence demonstrates that continuous positive airway pressure (CPAP) can improve symptoms such as daytime sleepiness among patients with ...