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Sleep Stimulation to Enhance Waste Clearance in the Brain

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Secondary endpoints: details revised at 2 of 9 entries
    • Eligibility criteria shortened, about 3 words
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT07051239
Lead Sponsor Erasme University Hospital
Collaborators: University of Amsterdam
Conditions
(from sponsor)		 Healthy, Subjective Cognitive Decline (SCD), Mild Cognitive Impairment (MCI), Alzheimer Disease (AD)
Related terms Alzheimer Disease, Cognitive Dysfunction
Enrollment 105 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov