Preventing Cognitive Decline Using Portable, Non-invasive Sleep Enhancement
概览
- 阶段
- 不适用
- 干预措施
- Phase-locked auditory stimulation (PLAS)
- 疾病 / 适应症
- Cognitive Decline
- 发起方
- University of Bern
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Episodic memory performance differences (between and within subject) according to the experimental condition
- 状态
- 招募中
- 最后更新
- 29天前
概览
简要总结
This study aims to explore a non-invasive way to improve memory and slow cognitive decline in older adults by enhancing sleep quality. Dementia, a leading cause of death worldwide, is often associated with disturbed sleep, particularly the loss of deep, slow-wave sleep (SWS). SWS is important for memory and clearing waste from the brain. Poor SWS can worsen memory loss and allow harmful waste to build up, which may increase the risk of dementia.
The investigators are testing whether phase-locked auditory stimulation (PLAS) can improve SWS in people at a mild stage of cognitive impairment. PLAS uses short sounds played at specific moments to strengthen slow-wave brain activity during sleep. The investigators previous laboratory based research has shown that this can improve memory and help with clearing waste from the brain. Now, the investigators want to test this in a real-world setting, over a longer period, which is unfeasible in a laboratory setting.
In this study, 60 older adults will use home-use devices that deliver either real or sham (soundless) PLAS across two different 4-week periods. Memory will be tested using engaging "serious games." Before and after each experimental period, blood samples will be taken to measure dementia-related markers, and cognitive batteries will be performed. The investigators expect that PLAS will improve sleep, and that this will have a downstream effect on memory and brain clearance, potentially slowing the process of cognitive decline.
If successful, this could lead to the development of an affordable treatment that helps people maintain brain health and prevent dementia.
研究者
入排标准
入选标准
- •Written informed consent
- •Age between 60 and 85 years
- •Cognitive impairment (subjective and/or MoCA between 23-26)
- •Native German speakers or comparably fluent
- •Normal or corrected-to-normal vision.
- •Intact hearing
- •A close cohabitant (partner/sibling) should be present to support participants in using study materials/devices.
排除标准
- •Insomnia assessed by the Regensburg Insomnia Scale (RIS; Crönlein et al., 2013)
- •Restless leg syndrome assessed by questions concerning typical symptoms.
- •Sleep apnoea assessed by the Berlin Questionnaire (BQ; Netzer et al., 1999)
- •Severely irregular sleep patterns assessed by the RIS and the Pittsburgh sleep quality index (PSQI; Buysse et al., 1989)
- •Symptoms of depression (Geriatric Depression Scale (GDS; Yesavage et al., 1982) ≥ 5)
- •History of untreated severe neurological and psychiatric diseases
- •Alcohol or substance abuse
- •Use of medication acting on the central nervous system
研究组 & 干预措施
PLAS first, sham second
In this study arm, participants will undergo a 4-week intervention period with real phase-locked auditory stimulation (PLAS) administered on nights from Monday to Friday. Following this initial intervention period, participants will have a 2-week washout phase. Finally, participants will enter the second intervention period, during which sham (soundless) PLAS will be administered.
干预措施: Phase-locked auditory stimulation (PLAS)
PLAS first, sham second
In this study arm, participants will undergo a 4-week intervention period with real phase-locked auditory stimulation (PLAS) administered on nights from Monday to Friday. Following this initial intervention period, participants will have a 2-week washout phase. Finally, participants will enter the second intervention period, during which sham (soundless) PLAS will be administered.
干预措施: Sham Phase-Locked Auditory Stimulation
Sham first, PLAS second
In this study arm, participants will undergo a 4-week intervention period with sham (soundless) phase-locked auditory stimulation (PLAS) administered on nights from Monday to Friday. Following this initial intervention period, participants will have a 2-week washout phase. Finally, participants will enter the second intervention period, during which real PLAS will be administered.
干预措施: Phase-locked auditory stimulation (PLAS)
Sham first, PLAS second
In this study arm, participants will undergo a 4-week intervention period with sham (soundless) phase-locked auditory stimulation (PLAS) administered on nights from Monday to Friday. Following this initial intervention period, participants will have a 2-week washout phase. Finally, participants will enter the second intervention period, during which real PLAS will be administered.
干预措施: Sham Phase-Locked Auditory Stimulation
结局指标
主要结局
Episodic memory performance differences (between and within subject) according to the experimental condition
时间窗: Participants will play serious games on weekdays during the adaptation week, as well as on weekdays throughout both the first and second 4-week intervention periods.
Episodic memory performance will be assessed by means of serious games.
次要结局
- Electrophysiological Response - Event-Related Potentials (ERPs)(Sleep-Electrophysiology will be measured on weekdays during the adaptation week, as well as on weekdays throughout both the first and second 4-week intervention periods.)
- Electrophysiological Response - Power, Number, and Amplitude of Slow Oscillations (SO) and Spindles(Sleep-electrophysiology will be measured on weekdays during the adaptation week, as well as on weekdays throughout both the first and second 4-week intervention periods.)
- Electrophysiological Response - Coupling of Slow Oscillations and Sleep Spindles(Sleep-electrophysiology will be measured on weekdays during the adaptation week, as well as on weekdays throughout both the first and second 4-week intervention periods.)
- Amyloid-Beta Response(At baseline, after 4 weeks, after 6 weeks, after 10 weeks)
- Electrophysiology - Brain Age Estimation(Sleep electrophysiology will be measured on weekdays during the adaptation week and on weekdays throughout both the first and second 4-week intervention periods.)