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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
Fluent in English or Spanish
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one-year follow-up
Awards & highlights

MCI:OSA Trial 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.Check my eligibility
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.See study design
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.

MCI:OSA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fluent in either English or Spanish.
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I have moderate to severe sleep apnea or no sleep apnea based on a sleep study.
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My memory test scores are slightly below normal for my age and education level.
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My medication, including antidepressants, has been stable for at least 4 weeks.
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I am between 55 and 85 years old.
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I can see and hear well enough for tests.
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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.

MCI:OSA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one-year follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and one-year follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Digit Symbol-Coding test
Secondary outcome measures
Clinical Dementia Rating Scale

MCI:OSA 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: CPAP non-adherentActive Control1 Intervention
Study participants in this arm are not using the CPAP intervention consistently
Group III: No OSAActive Control1 Intervention
Study participants who do not have OSA
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
1,992 Previous Clinical Trials
42,875,033 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,655 Previous Clinical Trials
28,003,843 Total Patients Enrolled
Nalaka Gooneratne, MD, MScPrincipal InvestigatorAssociate Professor
2 Previous Clinical Trials
27 Total Patients Enrolled

Media Library

CPAP (Positive Airway Pressure Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03113461 — N/A
Obstructive Sleep Apnea Research Study Groups: CPAP non-adherent, No OSA, CPAP adherent
Obstructive Sleep Apnea Clinical Trial 2023: CPAP Highlights & Side Effects. Trial Name: NCT03113461 — N/A
CPAP (Positive Airway Pressure Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03113461 — N/A
Obstructive Sleep Apnea Patient Testimony for trial: Trial Name: NCT03113461 — N/A

Frequently Asked Questions

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

Are there still spaces available in this clinical trial?

"The information hosted on clinicaltrials.gov discloses that this trial is not presently recruiting patients. This research project, which was originally published on October 15th 2017 and last updated August 30th 2022, is currently inactive - nonetheless, 853 other medical studies are actively seeking participants."

Answered by AI

To what degree must participants fulfill the criteria to be enrolled in this experiment?

"This scientific trial is looking for 327 participants between the ages of 55 and 85 who have been diagnosed with obstructive sleep apnea. In addition to this, potential candidates must satisfy a range of criteria such as scoring between 23-30 on the MMSE (with exceptions possible), an AHI greater than or equal to 15 events/hr, a CDR score of 0-0.5, memory impairment within 1 standard deviation below normal adjusted for age and education determined by Logical Memory II scores from the Wechsler memory scale; no depressive symptoms scored lower than 6 on GDS etc., along with having sufficient visual and auditory ac"

Answered by AI

Is the eligibility criteria for this medical experiment including those of advanced age?

"The age range for participants in this trial is 55 to 85, according to the criteria set forth."

Answered by AI

In what number of health care facilities is this trial taking place?

"Washington University in St. Louis, University of Pennsylvania, and the University of Virginia are three major sites running this trial with an additional four locations accounting for enrolment as well."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
Texas
Maryland
How old are they?
18 - 65
What site did they apply to?
University of Pennsylvania
University of Texas at Austin
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
1
3+

Why did patients apply to this trial?

Clap intolerable.. seeking other options. I'm in a seemingly endless downward spiral with less and less hope for my existence.
PatientReceived 1 prior treatment
I've tried to use the CPAP it just doesn't seem like it is working. It makes my heart feel a certain way.
PatientReceived 1 prior treatment
Diagnosed with mild cognitive impairment and want to prevent progression. Also have mild sleep apnea diagnosis.
PatientReceived 1 prior treatment
~46 spots leftby Mar 2025