Sleep Stimulation to Enhance Waste Clearance in the Brain

Официальное название

Enhancing Waste Clearance Through Sleep Stimulation

Обзор

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Plasma biomarkers [Срок оценки: Blood samples will be collected the morning after each intervention phase. Interventions are separated by one week.]

Вторичные конечные точки (9)

• Glymphatic function [Срок оценки: MRI scans will be performed the morning after each intervention phase. Interventions are separated by one week.]
• CLAS evoked responses [Срок оценки: Each night of sleep during each intervention phase, whether receiving stimulation or sham.]
• Slow wave activity (SWA) [Срок оценки: Each night of sleep during each intervention phase, whether receiving stimulation or sham.]
• Sleep architecture [Срок оценки: Each night of sleep during each intervention phase, whether receiving stimulation or sham.]
• Change in memory performance [Срок оценки: Before and after each intervention period. Interventions are separated by one week.]
• Encoding capacity [Срок оценки: After each intervention phase. Interventions are separated by one week.]
• Alertness and sustained attention [Срок оценки: The PVT task will be assessed before and after each intervention phase. Interventions are separated by one week.]
• Subjective measures after sleep [Срок оценки: Each morning throughout the intervention phase.]
• Resting-state functional connectivity [Срок оценки: MRI scans will be performed the morning after each intervention phase. Interventions are separated by one week.]

Критерии участия

For the positive amyloid load group:

-Participants who meet the criteria of subjective cognitive decline or mild cognitive impairment (Clinical Dementia Rating < 2; Mini-Mental State Examination ≥ 21) and brain amyloid-beta (Aβ) accumulation confirmed by CSF or amyloid-PET, the inclusion age range is 55-80 years.

For healthy groups:

-Inclusion age range is 18-80 years.

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Фундаментальное исследование

Центры проведения

Бельгия · 1 центр

• Hôpital Universitaire de Bruxelles — Brussels

Идентификаторы

NCT: NCT07051239 · HUB2025028

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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