Exploring the Recovery Function of Sleep in Neurodegeneration - an Observational Cross-Sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Performance change in behavioral/cognitive tasks
研究概览
简要总结
The overall objective of this study is to identify the best approach for assessing the recovery function of sleep in neurodegenerative diseases associated with abnormal protein aggregation with regard to the conception of future intervention studies. To this end, the investigators will follow an exploratory approach in a preferably broad data set collected in patients with neurodegenerative diseases associated with abnormal protein aggregation and in healthy humans.
详细描述
First, the investigators want to assess the relationship between sleep parameters (e.g. sleep intensity) and behavioral/cognitive performance and subjective measures (e.g. sleep quality, mood, and sleepiness) in patients with neurodegenerative disorders associated with abnormal protein aggregation. Healthy subjects will be assessed for procedure validation and reference purposes. Second, the investigators want to probe whether associations can be influenced by modulation of sleep parameters by means of auditory stimulation.
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
- Double (Participant, Outcomes Assessor)
盲法说明
During data collection, participants will be blinded to the condition, i.e. sham or verum stimulation. All experimenters will be blind for processing and analysis of outcome measures.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good general health or confirmed diagnosis of neurodegenerative disease associated with abnormal protein aggregation along international criteria
- •Age above 18 years
- •In ambulant setting: ability to apply the ambulant EEG device for the duration of the study, either alone or with help of co-habitant if MoCA < 20
排除标准
- •Failure to give informed consent
- •Inability to follow the procedures of the study, e.g. due to language problems or cognitive deficits
- •Known or suspected non-compliance, drug- or medication abuse
- •Inability to hear the tones to be applied during sleep in auditory stimulation experiments
- •Skin disorders/problems/allergies in face/ear area that could worsen with electrode application
- •Regular intake of drugs that may alter the relationship between sleep and outcome variables under investigation (opioids, benzodiazepines and z-drugs (nonbenzodiazepines)).
- •Clinically significant concomitant disease states
- •Too high (disease) burden for patients
- •Additional non-medical exclusion criteria may be defined for certain cognitive tasks (e.g. no glasses during experiments involving eye tracking)
研究组 & 干预措施
Verum stimulation
Verum condition: Auditory stimulation during sleep
干预措施: Auditory stimulation (Behavioral)
Sham stimulation
Sham condition: Playing no tones during sleep but still recording brain activity (muted tones)
干预措施: Auditory stimulation (Behavioral)
结局指标
主要结局
Performance change in behavioral/cognitive tasks
时间窗: measured before and after 4 nights
e.g. reaction time
Electrophysiological markers of brain activity during sleep as measured with EEG
时间窗: measured during 4 nights
e.g. slow wave activity (SWA)
Change in outcomes of subjective measures
时间窗: measured before and after 4 nights
e.g. sleepiness (scale from 1 to 10)
次要结局
- Outcomes of other physiological measures during sleep(measured during 4 nights)
- Outcomes of other physiological measures during behavioral tasks(measured before and after 4 nights)