Sleep Stimulation to Enhance Waste Clearance in the Brain

NCT ID: NCT07051239

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2028-09-30

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Healthy young, auditory stimulation, then sham

Group Type: EXPERIMENTAL

Closed-loop acoustic stimulation

Intervention Type: OTHER

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.

Healthy young, sham, then auditory stimulation

Group Type: EXPERIMENTAL

Closed-loop acoustic stimulation

Intervention Type: OTHER

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.

Healthy old, auditory stimulation, then sham

Group Type: EXPERIMENTAL

Closed-loop acoustic stimulation

Intervention Type: OTHER

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.

Healthy old, sham then auditory stimulation

Group Type: EXPERIMENTAL

Closed-loop acoustic stimulation

Intervention Type: OTHER

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.

Positive amyloid load group, auditory stimulation, then sham

Group Type: EXPERIMENTAL

Closed-loop acoustic stimulation

Intervention Type: OTHER

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.

Positive amyloid load group, sham, then auditory stimulation

Group Type: EXPERIMENTAL

Closed-loop acoustic stimulation

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

For healthy groups:

-Inclusion age range is 18-80 years.

• 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.

Exclusion Criteria

• 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.
• Ongoing treatment with psychotropic medications (benzodiazepines, antidepressants).
• Regular or excessive consumption of alcohol or caffeinated drinks.
• Consumption of other psychoactive substances known to have an impact on the central nervous system.
• Insufficient visual or auditory acuity to complete the assessments if uncorrected. Normal hearing is required for sound stimulation to be effective.
• Claustrophobia that prevents undergoing brain imaging (MRI).
• Pregnancy or currently breastfeeding

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Amsterdam

OTHER

Sponsor Role: collaborator

Erasme University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mélanie Strauss, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Université Libre de Bruxelles

Locations

Hôpital Universitaire de Bruxelles

Brussels, , Belgium

Countries

Belgium

Central Contacts

Mélanie Strauss, MD, PhD

Role: CONTACT

melanie.strauss@hubruxelles.be

+32 2 555 55 39

Rebeca Sifuentes Ortega, PhD

Role: CONTACT

rebeca.sifuentes.ortega@ulb.be

Facility Contacts

Mélanie Strauss

Role: primary

melanie.strauss@hubruxelles.be

+32 2 555 55 39

Other Identifiers

HUB2025028

Identifier Type: -

Identifier Source: org_study_id