NCT07051239

Sleep Stimulation to Enhance Waste Clearance in the Brain

Enhancing Waste Clearance Through Sleep Stimulation

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: Erasme University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy
• Subjective Cognitive Decline (SCD)
• Mild Cognitive Impairment (MCI)
• Alzheimer Disease (AD)

Interventions

Type	Name	Description
OTHER	Closed-loop acoustic stimulation	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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2025-07-04
• Last updated: 2025-07-09

Locations

1 site across 1 country: Belgium