Enhancing Waste Clearance Through Sleep Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Plasma biomarkers
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
- •Inclusion criteria:
- •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.
排除标准
- •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
研究组 & 干预措施
Healthy young, auditory stimulation, then sham
干预措施: Closed-loop acoustic stimulation (Other)
Healthy young, sham, then auditory stimulation
干预措施: Closed-loop acoustic stimulation (Other)
Healthy old, auditory stimulation, then sham
干预措施: Closed-loop acoustic stimulation (Other)
Healthy old, sham then auditory stimulation
干预措施: Closed-loop acoustic stimulation (Other)
Positive amyloid load group, auditory stimulation, then sham
干预措施: Closed-loop acoustic stimulation (Other)
Positive amyloid load group, sham, then auditory stimulation
干预措施: Closed-loop acoustic stimulation (Other)
结局指标
主要结局
Plasma biomarkers
时间窗: Blood samples will be collected the morning after each intervention phase. Interventions are separated by one week.
Levels of plasma biomarkers associated with neurodegeneration and brain health will be compared between stimulation and sham interventions.
次要结局
- Change in memory performance(Before and after each intervention period. Interventions are separated by one week.)
- Alertness and sustained attention(The PVT task will be assessed before and after each intervention phase. Interventions are separated by one week.)
- Encoding capacity(After each intervention phase. Interventions are separated by one week.)
- Alertness and sustained attention(The PVT task will be assessed before and after each intervention phase. Interventions are separated by one week.)
- Glymphatic function(MRI scans will be performed the morning after each intervention phase. Interventions are separated by one week.)
- CLAS evoked responses(Each night of sleep during each intervention phase, whether receiving stimulation or sham.)
- Slow wave activity (SWA)(Each night of sleep during each intervention phase, whether receiving stimulation or sham.)
- Sleep architecture(Each night of sleep during each intervention phase, whether receiving stimulation or sham.)
- Change in memory performance(Before and after each intervention period. Interventions are separated by one week.)
- Subjective measures after sleep(Each morning throughout the intervention phase.)
- Resting-state functional connectivity(MRI scans will be performed the morning after each intervention phase. Interventions are separated by one week.)
- Glymphatic function(MRI scans will be performed the morning after each intervention phase. Interventions are separated by one week.)
- CLAS evoked responses(Each night of sleep during each intervention phase, whether receiving stimulation or sham.)
- Slow wave activity (SWA)(Each night of sleep during each intervention phase, whether receiving stimulation or sham.)
- Encoding capacity(After each intervention phase. Interventions are separated by one week.)
- Sleep architecture(Each night of sleep during each intervention phase, whether receiving stimulation or sham.)
- Subjective measures after sleep(Each morning throughout the intervention phase.)
- Resting-state functional connectivity(MRI scans will be performed the morning after each intervention phase. Interventions are separated by one week.)