NCT07911826Not yet recruiting
Targeting Sleep and Slow-Wave Activity to Enhance Cognition in MCI
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
Study Description As most clinical trials in Alzheimer's disease (AD) have been unsuccessful to date, it has become increasingly crucial to focus on treating earlier stages of the disease. Compelling evidence indicates that sleep disruption is associated with accumulation of Alzheimer's biomarkers, including amyloid-beta (Aβ) and tau pathology. Slow-wave activity (SWA) during sleep is particularly important for the clearance of Aβ and sleep-dependent memory consolidation, and sleep disturbance could reduce the amount of time spent in slow-wave sleep. Together, these findings suggest that treating sleep disruption in older adults may help reduce the level of adverse brain aging. The goal of this study is to better understand the effect of sleep interventions on improving sleep and building cognitive resilience in older adults with amnestic mild cognitive impairment (aMCI), and to assess the feasibility of relevant study protocols. Fifty older adults (ages 60-85) with aMCI and sleep disturbance (Insomnia Severity Index score of 8 or greater) will be randomized 1:1 to one of two treatment arms: Cognitive Behavioral Therapy for Insomnia only (CBT-I + Sham), or CBT-I combined with acoustic slow-wave activity enhancement (CBT-I + SWAE). CBT-I is a psychotherapy intervention designed to address maladaptive cognitive and behavioral patterns associated with sleep and bedtime. SWAE is administered through non-invasive earbuds (Smartbuds, NextSense Inc.) that detect and amplify endogenous slow-wave activity using acoustic pulses during sleep. Each participant will complete 3 visits over approximately 6 months: a baseline visit, a post-treatment visit (approximately 12 weeks after baseline), and a 6-month follow-up visit. Group differences will be compared on changes in cognitive performance and plasma biomarkers of AD (phosphorylated tau \[pTau-217\]) across these time points. The study will also explore potential mechanisms behind the relationship between sleep and cognition/biomarkers by investigating a range of objectively measured sleep metrics (e.g., sleep architecture, sleep duration, arousals) along with depressive symptoms. Hypotheses: CBT-I will be associated with more favorable outcomes (i.e., less decline or greater improvement) in frontal network functioning (sustained attention/target detection, executive functions), while SWAE will be associated with better outcomes in measures of episodic memory (word-list learning and story recall). Improvements in total sleep time and insomnia symptoms at 8 weeks are hypothesized to mediate the relationship between CBT-I and performance on attention and executive functions over 6 months, while improvements in slow-wave non-rapid eye movement (NREM) sleep at 12 weeks are hypothesized to mediate the relationship between SWAE and episodic memory measures. Additionally, CBT-I is hypothesized to be associated with increased scores on the Visuospatial Abilities, Planning, Organization, and Divided Attention subscales of the Everyday Cognition (ECog) questionnaire after 6 months, while SWAE is hypothesized to be associated with a significant increase in the Everyday Memory subscale. Objectives: Aim 1: To determine if CBT-I and SWAE have different neuropsychological outcomes in aMCI. Aim 2: To examine the impact of sleep treatments on cognitively mediated everyday functioning. Exploratory Aim: To assess whether CBT-I and/or SWAE are associated with changes in plasma pTau and whether pTau moderates the association between sleep and cognition. Results from this study will determine whether sleep interventions can build brain and cognitive resilience in the context of aging, and will inform the design of a future, larger-scale R01 study rigorously examining the association between targeted sleep modifications and markers of AD pathophysiology as a potentially modifiable risk factor for dementia.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 27 Oct 2026
- Start date
- Jan 2027
- Primary completion date
- Jun 2029
- Lead sponsor
- New York State Psychiatric Institute
- Diseases
- Alzheimer disease
- NCT number
- NCT07911826
What you commit to
- Study type: Interventional
- Planned participants: 50
- From Jan 2027 to the primary completion date, Jun 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diagnosis of stroke or excessive cardiovascular disease risk Neurologic disease, including movement disorders, multiple sclerosis, epilepsy, or traumatic brain injury with loss of consciousness \>15 minutes Untreated diabetes Active cancer treatment Telephone MMSE score below 22, or Logical Memory score above education-adjusted cutoffs (indicating no cognitive impairment) Sleep disorders other than insomnia (moderate-to-severe sleep apnea, REM behavior disorder, restless legs syndrome, circadian rhythm disorder); mild sleep apnea is not exclusionary Current DSM-5 diagnosis of schizophrenia, schizoaffective disorder, substance/alcohol use disorder, or bipolar disorder Use of sleep aids (prescription or OTC) within the past 14 days Use of antidepressants with significant anticholinergic properties (e.g., amitriptyline, doxepin, mirtazapine - full list in protocol) Use of benzodiazepines (e.g., diazepam, lorazepam, alprazolam - full list in protocol) Moderate-to-severe depression (Geriatric Depression Scale \>8) Inability to provide an informant
Who the study is looking for
- English speaking, ages 60-85 years Telephone MMSE (T-MMSE) score of 22 or greater at screening Diagnosis of amnestic MCI, per Logical Memory (LM) delayed recall and QDRS criteria (education-adjusted LM cutoffs; QDRS total ≥1.5 with memory subscore ≥0.5) Presence of sleep disturbance, defined as Insomnia Severity Index (ISI) score ≥8 at baseline Capacity to provide informed consent Access to a stable internet connection Availability of a family member or other informant in regular contact with the participant, willing to serve as an informant (telephone informant acceptable)
Age in the registry: 60 years to 85 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.