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Positive Airway Pressure Therapy
CPAP for Mild Cognitive Impairment Due to Sleep Apnea (MCI:OSA Trial)
N/A
Waitlist Available
Led By Nalaka Gooneratne, MD, MSc
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Moderate to severe OSA as defined by an AHI ≥ 15 events/hr, or no apnea defined by an AHI<5 events/hr using American Academy of Sleep Medicine (AASM) diagnostic methodology as determined on a diagnostic polysomnography
Memory impairment approximately 1.0-1.5 standard deviations below normal (adjusted for age and education) determined by scores on the Logical Memory II a test from the Wechsler memory scale
Must not have
Within the past 6 months brain tumor, or seizure disorder, or subdural hematoma, or post-stroke (based on Modified Hachinski Ischemic Score)
Any significant neurologic disease other than aMCI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one-year follow-up
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether treating obstructive sleep apnea can delay cognitive impairment in patients with mild cognitive impairment.
Who is the study for?
This trial is for adults aged 55-85 with mild cognitive impairment and moderate to severe obstructive sleep apnea, who are not depressed or suffering from significant neurological diseases other than amnestic MCI. Participants must have stable medication use, a study partner, be fluent in English or Spanish, and able to complete the study's requirements.
What is being tested?
The trial is testing if using CPAP therapy can slow down cognitive decline in patients with memory issues due to amnestic Mild Cognitive Impairment. It involves baseline assessments, follow-ups at six months (cognitive tests only), and one year with both cognitive tests and brain MRI scans.
What are the potential side effects?
CPAP treatment may cause discomfort such as nasal congestion, dry mouth, sore throat, headaches, stomach bloating and difficulty falling asleep. Some people might also feel claustrophobic wearing the CPAP mask.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have moderate to severe sleep apnea or no sleep apnea based on a sleep study.
Select...
My memory test scores are slightly below normal for my age and education level.
Select...
I am between 55 and 85 years old.
Select...
I can see and hear well enough for tests.
Select...
I am post-menopausal or have been surgically sterilized.
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I am between 55 and 85 years old.
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I have moderate to severe sleep apnea or no sleep apnea based on a sleep study.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had a brain tumor, seizure, bleeding in the brain, or stroke in the last 6 months.
Select...
I do not have any major neurological conditions except for mild cognitive impairment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one-year follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one-year follow-up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Digit Symbol-Coding test
Secondary study objectives
Clinical Dementia Rating Scale
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: CPAP adherentExperimental Treatment1 Intervention
Study participants in this arm are using the CPAP intervention consistently
Group II: No OSAActive Control1 Intervention
Study participants who do not have OSA
Group III: CPAP non-adherentActive Control1 Intervention
Study participants in this arm are not using the CPAP intervention consistently
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CPAP
2013
Completed Phase 3
~5460
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,078 Previous Clinical Trials
42,721,058 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,788 Previous Clinical Trials
28,184,186 Total Patients Enrolled
Nalaka Gooneratne, MD, MScPrincipal InvestigatorAssociate Professor
2 Previous Clinical Trials
27 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fluent in either English or Spanish.If you scored between 28 and 35 on the optional cognitive test over the phone.I have used a CPAP or BiPAP machine regularly for my sleep apnea in the last 6 months.You have a low score on a test for depression called the Geriatric Depression Scale.You are not feeling very sad or down, based on a test called the Geriatric Depression Scale.I have not had a brain tumor, seizure, bleeding in the brain, or stroke in the last 6 months.You need to score between 23-30 on a test called the Mini Mental State Examination (MMSE). If you have less than 8 years of education, the research team might make an exception.Your memory test scores are significantly lower than normal for your age and education level.I am fluent in English or Spanish.I do not have any serious illnesses that would make following the study rules hard for me.You have serious mental health conditions like major depression, bipolar disorder, or schizophrenia that could make it hard for you to follow the study rules.I have moderate to severe sleep apnea or no sleep apnea based on a sleep study.You have very mild or no signs of dementia according to the Clinical Dementia Rating Scale.My memory test scores are slightly below normal for my age and education level.My medication, including antidepressants, has been stable for at least 4 weeks.I am between 55 and 85 years old.I do not have any major neurological conditions except for mild cognitive impairment.I can see and hear well enough for tests.You have had a problem with drinking too much alcohol in the last 6 months.You have very mild to no signs of dementia according to the CDR scale.My medication, including antidepressants, has been stable for at least 4 weeks.I am post-menopausal or have been surgically sterilized.I am between 55 and 85 years old.If you score between 28 and 35 on the optional cognitive screening test, you may be eligible.You have already taken part in neuropsychological studies more than twice in a year.You need to score a certain range on a memory and thinking test, but if you have had less than 8 years of education, the clinical research team may make an exception.I have moderate to severe sleep apnea or no sleep apnea based on a sleep study.
Research Study Groups:
This trial has the following groups:- Group 1: No OSA
- Group 2: CPAP non-adherent
- Group 3: CPAP adherent
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Obstructive Sleep Apnea Patient Testimony for trial: Trial Name: NCT03113461 — N/A
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