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Behavioural Intervention

CPAP Therapy for Alzheimer's Disease

Phase 1

Recruiting

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Independently living and able to drive

Age 65-85 years

Must not have

Presence of a brain tumor or lobar stroke

History of COPD or asthma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Summary

This trial will test whether a device that helps with sleep apnea will also help with Alzheimer's disease.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Using a CPAP machine may cause discomfort such as nasal congestion or dryness while supplemental oxygen could lead to dry or bloody nose and morning headaches. Room air has no associated side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I live on my own and can drive.

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I am between 65 and 85 years old.

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I have sleep apnea with an AHI of 15 or higher, or I do not have sleep apnea.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have a history of COPD or asthma.

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I am unable to complete English-only study materials.

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I am unable to understand and make decisions about my medical care.

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I do not have severe heart failure, unstable heart disease, or uncontrolled high blood pressure.

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I have a neuromuscular disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Apnea Hypopnea Index

Loop Gain (LG)

Neuroimaging

Secondary study objectives

Epworth Sleepiness Scale (ESS)

Insomnia Severity Index (ISI)

Pittsburg Sleep Quality Index (PSQI)

Trial Design

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.

0 / 9Eligibility criteria met