260 Participants Needed

CPAP Therapy for Alzheimer's Disease

Recruiting at 1 trial location
PD
DG
PD
Overseen ByPam DeYoung
Age: 65+
Sex: Any
Trial Phase: Phase 1
Sponsor: University of California, San Diego

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.12345

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.13456

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.13457

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)
See 3 more

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.
See 8 more

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
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Supplemental Oxygen for 3 MonthsExperimental Treatment1 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 MonthsExperimental Treatment1 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 PSGActive Control1 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 PSGPlacebo Group1 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.

Find a Clinic Near You

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.
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.
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.
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]

References

Adherence to continuous positive airway pressure treatment in patients with Alzheimer's disease and obstructive sleep apnea. [2017]
Cognitive effects of treating obstructive sleep apnea in Alzheimer's disease: a randomized controlled study. [2022]
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]
Continuous positive airway pressure deepens sleep in patients with Alzheimer's disease and obstructive sleep apnea. [2021]
Continuous positive airway pressure reduces subjective daytime sleepiness in patients with mild to moderate Alzheimer's disease with sleep disordered breathing. [2008]
The LeVe CPAP System for Oxygen-Efficient CPAP Respiratory Support: Development and Pilot Evaluation. [2023]
Continuous Positive Airway Pressure Treatment in Patients with Alzheimer's Disease: A Systematic Review. [2020]