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

Trial Summary

What is the purpose of this trial?

Obstructive sleep apnea (OSA) is common in older adults and has recently been implicated in pathogenesis of Alzheimer's disease (AD). Research has shown that sleep disruptions have caused memory impairment. Sleep apnea is a form of sleep disruption. We would like to examine how obstructive sleep apnea may contribute to the progression of Alzheimer's disease.

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.

What data supports the effectiveness of CPAP treatment for Alzheimer's disease?

Research shows that using CPAP treatment in patients with Alzheimer's disease and obstructive sleep apnea can improve cognitive function, slow cognitive decline, enhance sleep quality, and reduce daytime sleepiness. ^{1 2 3 4 5}

Is CPAP therapy safe for use in humans?

CPAP therapy has been shown to be safe and well-tolerated in both patients with Alzheimer's disease and healthy volunteers, with no adverse events reported in studies. ^{1 3 4 5 6}

How does CPAP treatment for Alzheimer's differ from other treatments?

CPAP (Continuous Positive Airway Pressure) treatment is unique for Alzheimer's patients as it addresses sleep-disordered breathing, which is common in these patients, by providing a steady flow of air to keep airways open during sleep. This treatment not only improves sleep quality but also helps slow cognitive decline and reduces daytime sleepiness, which are not typically targeted by standard Alzheimer's treatments. ^{1 3 4 5 7}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Adherence to continuous positive airway pressure treatment in patients with Alzheimer's disease and obstructive sleep apnea. [2017]

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

Cognitive effects of treating obstructive sleep apnea in Alzheimer's disease: a randomized controlled study. [2022]

3. United States 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. [2022]

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

Continuous positive airway pressure deepens sleep in patients with Alzheimer's disease and obstructive sleep apnea. [2021]

5. United States 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. [2008]

6. Switzerland pubmed.ncbi.nlm.nih.gov

The LeVe CPAP System for Oxygen-Efficient CPAP Respiratory Support: Development and Pilot Evaluation. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Continuous Positive Airway Pressure Treatment in Patients with Alzheimer's Disease: A Systematic Review. [2020]