Sleep Stimulation to Enhance Waste Clearance in the Brain
Enhancing Waste Clearance Through Sleep Stimulation
Enhancing Waste Clearance Through Sleep Stimulation
Sponsor study identifier
interventional
105
1 country
1
Study Start
September 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 26, 2025
Actual (reported)July 4, 2025
Actual (reported)September 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Plasma biomarkers
Levels of plasma biomarkers associated with neurodegeneration and brain health will be compared between stimulation and sham interventions.
Blood samples will be collected the morning after each intervention phase. Interventions are separated by one week.
Glymphatic function
MRI scans will be performed the morning after each intervention phase. Interventions are separated by one week.
CLAS evoked responses
Each night of sleep during each intervention phase, whether receiving stimulation or sham.
Slow wave activity (SWA)
Each night of sleep during each intervention phase, whether receiving stimulation or sham.
Sleep architecture
Each night of sleep during each intervention phase, whether receiving stimulation or sham.
Change in memory performance
Before and after each intervention period. Interventions are separated by one week.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hôpital Universitaire de Bruxelles
Brussels, Belgium
Mélanie Strauss, MD, PhD
Université Libre de Bruxelles
First Submitted
June 26, 2025
First Posted
July 4, 2025
Study Start
September 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 2028
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 9, 2025
Record last verified: 2025-06
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Source: ClinicalTrials.gov.
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