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CPAP for Mild Cognitive Impairment Due to Sleep Apnea (MCI:OSA Trial)
MCI:OSA Trial Summary
This trial will test whether treating obstructive sleep apnea can delay cognitive impairment in patients with mild cognitive impairment.
MCI:OSA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowMCI:OSA Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.MCI:OSA Trial Design
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Who is running the clinical trial?
Media Library
- 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 score on the Clinical Dementia Rating Scale (CDR) is between 0 and 0.5.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.
- Group 1: CPAP non-adherent
- Group 2: No OSA
- Group 3: CPAP adherent
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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"
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."
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."
Who else is applying?
What state do they live in?
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What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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