MCI: CPAP Treatment of OSA (Memories2) (NCT03113461) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
MCI: CPAP Treatment of OSA (Memories2)
United States327 participantsStarted 2018-01-19
Plain-language summary
The purpose of this project is to determine whether obstructive sleep apnea (OSA) treatment with positive airway pressure therapy (CPAP) can delay the progression of cognitive impairment in patients with amnestic Mild Cognitive Impairment (MCI) as measured by cognitive testing, and brain magnetic resonance imaging (MRI) scans. Study participants will be assessed at baseline, six-month (cognitive tests only) and one-year follow-up.
Who can participate
Age range
55 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. age 55-85 years;
. 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;
. Scoring education adjusted scores 28-35 (inclusive) on optional Telephone Interview for Cognitive Status Modified (pre-screen);
. Scoring 0-0.5 on the Clinical Dementia Rating Scale (CDR);
. Scoring 23-30 on the Mini Mental State Examination (MMSE) (exceptions may be made for participants with \<8 years of education as determined by the clinical research team);
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. permitted medications (antidepressants, etc.) stable for at least 4 weeks (12 weeks for cholinesterase inhibitors/memantine) as per ADNI3 criteria;
. Non-depressed: Scoring \< 6 on the Geriatric Depression Scale;
Exclusion criteria
. any significant neurologic disease other than aMCI, such as Parkinson's Disease, Huntington's disease, normal pressure hydrocephalus, progressive supranuclear palsy, multiple sclerosis, head trauma followed by permanent neurologic deficits or known congenital brain structure abnormalities; within the past 6 months brain tumor, or seizure disorder, or subdural hematoma, or post-stroke (based on Modified Hachinski Ischemic Score);
. Optional: MRI exclusions - presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin, or body; however, the participant has the option of participating in the study without having an MRI;
. psychiatric disorders, including uncontrolled major depression, newly diagnosed or exacerbation in past 6 months of bipolar disorder as described in the DSM-IV, psychotic features, agitation or behavioral problems within the past 6 months that could lead to difficulty complying with the protocol, or history of schizophrenia (DSM-IV criteria);
. history of alcohol abuse or dependence within the past 6 months (DSM-IV criteria);
. any current significant systemic illness or unstable medical condition that could lead to difficulty in complying with the protocol (such as unstable cardiovascular disease); current use of supplemental oxygen or hypoxemia indicated by documented daytime oxyhemoglobin saturation \<90% on room air, uncontrolled thyroid disease (to be included must be on stable dose of thyroid medication for \>6 months), uncontrolled cirrhosis, cancer diagnosis within the past 6 months (exceptions may be made at the PI's discretion depending on cancer severity and the treatment required), clinically significant laboratory abnormalities such as reported untreated folate, B12, or TSH disease, or resident of a skilled nursing facility;
. participation in clinical studies involving neuropsychological measures being conducted more than twice a year;
. received and was adherent to CPAP or bi-level pressure for OSA within the past 6 months;