Sleep Interventions and Neurocognitive Outcomes (NCT05987007) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Sleep Interventions and Neurocognitive Outcomes
United States50 participantsStarted 2026-07-01
Plain-language summary
This protocol focuses on the effect of sleep interventions on improving sleep and building cognitive/brain resilience in older adults with amnestic mild cognitive impairment and sleep disturbance. Two sleep interventions, cognitive behavioral therapy for insomnia (CBTI) and acoustic slow-wave activity enhancement (SWAE), will be utilized in a pilot randomized clinical trial in which participants are randomized to different treatment groups (CBTI or SWAE). Participants will be assessed over a 6-month period in order to examine the impact of sleep treatments on neuropsychological outcomes and cognitively mediated everyday functioning.
Who can participate
Age range
60 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
. English speaking participants, ages 60-85 years
. Telephone MMSE (T-MMSE) score of 22 or greater at screening assessment; T-MMSE \<18 during post-treatment visit or 6-month follow-up will be discontinued from participation of the study.
. Individuals with aMCI, as determined by the Wechsler Memory Scale-Revised Logical Memory Delayed Recall (LM) and Quick Dementia Rating Scale (QDRS)
Exclusion criteria
. Participants with regular and consistent use of sleep medications (sedatives/hypnotic use of \>3 times per week) will be excluded. Participants who take sleep medications 3 or less times per week will be asked to discontinue medications prior to the study baseline visit. All discontinuation/tapering procedures will require PI's direct consultation with participants' prescribing or primary care physicians, which will be documented to ensure participants' safety.
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.
1This trial focuses on people with both sleep disturbance and amnestic mild cognitive impairment — does my specific diagnosis and sleep history match what they're looking for, and is it worth waiting for this study to start recruiting before exploring other options?
2Since the trial is listed as 'not yet recruiting,' how long might it realistically be before it opens, and should we be pursuing other sleep or cognitive treatments in the meantime?
3The trial is measuring things like everyday memory functioning and attention using tests like the ECog and the Conners CPT-3 — what do those assessments involve, and how demanding would the testing schedule likely be for someone in my situation?
4Because this study is listed as Phase NA, meaning it may be more of a behavioral or observational intervention rather than a drug trial, can you help me understand what the actual sleep intervention might involve and whether there are similar approaches I could try now outside of a trial?
5Given that sleep problems can sometimes accelerate cognitive decline in people with mild cognitive impairment, would participating in a study like this offer any real advantage over standard sleep treatments my care team could already provide?
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.
. Presence of sleep disturbance, as determined by score of 8 or greater on the Insomnia Severity Index administered at baseline (without sleep medications).
. Participants must have capacity to provide informed consent.
. Have access to stable internet connection.
. A family member or other individual who is in contact with the subject and consents to serve as informant during the study; this can be a telephone informant in the case of subjects who do not have a live-in informant
. Diagnosis of stroke or excessive risk of CVD
. Neurologic disease including movement disorders, MS, epilepsy, and TBI (with greater than 15 min loc)