Sleep Stimulation to Enhance Waste Clearance in the Brain

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorErasme University Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Proficiency in the French language (close to native level) to complete the neuropsychological evaluation and cognitive tests.

MRI compatibility: absence of metallic materials in the body (implants, vascular clips, certain types of orthopedic material, etc.), a pacemaker or other types of stimulators, cochlear implants, or any other electronic devices.

Disqualifiers

Current or past psychiatric or neurological conditions (except for those directly associated with the patient group).

The presence of severe untreated sleep disorders.

The presence of irregular sleep-wake cycles (due to shiftwork or extreme chronotype).

The presence of moderate depression or high levels of anxiety.

Trial design

Treatments tested in this trial

  • Closed-loop acoustic stimulation

Treatment groups

105 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators

Erasme University Hospital

Lead sponsor

University of Amsterdam

Collaborator