About this trial
This study aims to examine whether multi-night closed-loop auditory stimulation (CLAS) during sleep can enhance waste clearance and memory consolidation in healthy adults and older adults with subjective cognitive decline or mild cognitive impairment who exhibit elevated brain amyloid levels identified through prior clinical screening. Specifically, the study investigates whether sleep stimulation increases the clearance of plasma biomarkers related to neurodegeneration, improves the brain's waste clearance system, and supports memory consolidation. Participants will undergo five nights each of CLAS and sham (no stimulation) interventions, with a washout period in between. They will also complete clinical assessments, including MRI scans, blood sample collection, and cognitive testing, and will keep track of subjective sleep quality, sleepiness, mood, and fatigue throughout the interventions.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Proficiency in the French language (close to native level) to complete the neuropsychological evaluation and cognitive tests.
MRI compatibility: absence of metallic materials in the body (implants, vascular clips, certain types of orthopedic material, etc.), a pacemaker or other types of stimulators, cochlear implants, or any other electronic devices.
Disqualifiers
Current or past psychiatric or neurological conditions (except for those directly associated with the patient group).
The presence of severe untreated sleep disorders.
The presence of irregular sleep-wake cycles (due to shiftwork or extreme chronotype).
The presence of moderate depression or high levels of anxiety.
Trial design
Crossover
Treatments tested in this trial
Closed-loop acoustic stimulation
Other interventionAt-home sleep will be monitored using an EEG headband. Non-awakening auditory stimuli will be delivered during non-rapid eye movement sleep (NREM), timed to the ascending phase of slow waves, using either active or control (sham) conditions.
Treatment groups
6
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
Plasma biomarkers
Levels of plasma biomarkers associated with neurodegeneration and brain health will be compared between stimulation and sham interventions.
Secondary outcomes
Glymphatic function
Magnetic resonance imaging (MRI) derived measures will serve as proxies for glymphatic function and will be compared between stimulation and sham interventions.
CLAS evoked responses
EEG responses locked to the acoustic stimulation will be examined (phase, amplitude, power, slow oscillations, spindle coupling) during stimulation and sham night recordings. Associations between APOE phenotype, age, amyloid accumulation, brain structure and function, baseline memory performance, sleep quality and responses to CLAS will be evaluated.
Slow wave activity (SWA)
EEG SWA will be assessed during NREM sleep periods from each intervention (stimulation and sham)
Sleep architecture
As measured with the EEG headband, macro- (e.g., duration, latency, distribution of sleep stages), and micro-architecture (slow waves, sleep spindles, rapid eye movements, arousals) differences between stimulation and sham conditions will be assessed.
Sponsors and contacts
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Erasme University Hospital
Lead sponsor
University of Amsterdam
Collaborator
This trial is not recruiting at the moment. You can still explore other options: