MedTrace Logo

Sleep Stimulation to Enhance Waste Clearance in the Brain

NCT07051239 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2025-07-09

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University of Amsterdam

    collaborator OTHER

  • Erasme University Hospital

    lead OTHER

Principal Investigators

  • Mélanie Strauss, MD, PhD · Université Libre de Bruxelles

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2028-09-30
Completion
2028-09-30

Countries

  • Belgium

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07051239 on ClinicalTrials.gov