Hôpital Universitaire de Bruxelles
Brussels, Belgium
NCT Number: NCT07051239
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.
Trial opening soon.
Get Notified18 year–80 year
All sexes
Interventional
Not applicable
Brussels, Belgium
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
For the positive amyloid load group:
-Participants who meet the criteria of subjective cognitive decline or mild cognitive impairment (Clinical Dementia Rating < 2; Mini-Mental State Examination ≥ 21) and brain amyloid-beta (Aβ) accumulation confirmed by CSF or amyloid-PET, the inclusion age range is 55-80 years.
For healthy groups:
-Inclusion age range is 18-80 years.
Inclusion criteria
Exclusion criteria
At-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.
Time frame: Blood samples will be collected the morning after each intervention phase. Interventions are separated by one week.
Levels of plasma biomarkers associated with neurodegeneration and brain health will be compared between stimulation and sham interventions.
Time frame: MRI scans will be performed the morning after each intervention phase. Interventions are separated by one week.
Magnetic resonance imaging (MRI) derived measures will serve as proxies for glymphatic function and will be compared between stimulation and sham interventions.
Time frame: Each night of sleep during each intervention phase, whether receiving stimulation or sham.
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.
Time frame: Each night of sleep during each intervention phase, whether receiving stimulation or sham.
EEG SWA will be assessed during NREM sleep periods from each intervention (stimulation and sham)
Time frame: Each night of sleep during each intervention phase, whether receiving stimulation or sham.
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.
Time frame: Before and after each intervention period. Interventions are separated by one week.
Performance change in declarative memory tasks (cued-recall and recognition measures) will be evaluated.
Time frame: After each intervention phase. Interventions are separated by one week.
Performance in a continuous mnemonic discrimination task (recognition and mnemonic discrimination measures) will be assessed after both stimulation and sham interventions.
Time frame: The PVT task will be assessed before and after each intervention phase. Interventions are separated by one week.
Performance (reaction times, lapses) in the psychomotor vigilance task (PVT).
Time frame: Each morning throughout the intervention phase.
As measured with morning questionnaires, subjective sleep quality, fatigue, sleepiness, mood, and affect, will be assessed every morning during each stimulation and sham intervention.
Time frame: MRI scans will be performed the morning after each intervention phase. Interventions are separated by one week.
Changes in resting-state functional connectivity measured with fMRI will be compared between stimulation and sham interventions.
Contact information is provided by the study sponsor or research team.
Mélanie Strauss, MD, PhD
CONTACT
Rebeca Sifuentes Ortega, PhD
CONTACT
Erasme University Hospital
Other
Enhancing Waste Clearance Through Sleep Stimulation
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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