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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Apnea Hypopnea Index
Loop Gain (LG)
Neuroimaging
Secondary outcome measures
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.

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,121 Previous Clinical Trials
1,521,165 Total Patients Enrolled

Media Library

Room Air (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05094271 — Phase 1
Alzheimer's Disease Research Study Groups: PAP Therapy for 3 Months, Supplemental Oxygen for 3 Months, Room Air during PSG, Supplemental Oxygen during PSG
Alzheimer's Disease Clinical Trial 2023: Room Air Highlights & Side Effects. Trial Name: NCT05094271 — Phase 1
Room Air (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05094271 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the capacity of this research study in terms of participants?

"That is correct. As detailed on clinicaltrials.gov, the study that was originally posted on June 30th 2021 is actively attempting to recruit 260 patients from 2 different medical centres."

Answered by AI

What criteria must potential participants meet to be eligible for this research endeavor?

"This medical experiment is seeking 260 elderly individuals aged 65 to 85 who have been diagnosed with Alzheimer's disease. The acknowledgements established by the researchers include: a minimum MOCA score of 26, independent living and driving capability, an apnea-hypopnea index (AHI) greater than 15/h or no evidence of OSA, and waiving their right to obtain their PHS score due to its lack of actionability potentially causing social tension or ethical conflict."

Answered by AI

Do any elderly individuals qualify for this research experiment?

"The requirements for this trial necessitate that potential candidates are aged 65 to 85. There is a total of 70 studies available for minors and 772 trials accessible to the elderly population."

Answered by AI

What risk factors have been associated with the use of Supplemental Oxygen?

"There is limited information on Supplemental Oxygen's efficacy and safety profile, thereby rating it a 1."

Answered by AI

Are physicians actively seeking volunteers for this experiment?

"Affirmative. The information featured on clinicaltrials.gov suggests this trial is currently enrolling patients, with the first posting taking place June 30th 2021 and the last update coming November 9th 2022. Two different medical centres are in search of a total of 260 participants for the study."

Answered by AI

Who else is applying?

What state do they live in?
Wisconsin
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Is Obstructive Sleep Apnea Important in the Development of Alzheimer's Disease?
Atul Malhotra 2021. "Is Obstructive Sleep Apnea Important in the Development of Alzheimer's Disease?". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05094271.
All > Apnea > Sleep
~59 spots leftby Mar 2025
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