Effect of Vestibular Stimulation on Sleep in Elderly
2019年8月7日 更新者：Swiss Federal Institute of Technology
Vestibular stimulation might be beneficial for sleep.
Previous research demonstrated that lateral rocking movements can facilitate the transition from wake to sleep during an afternoon nap.
However, the relationship between rocking movements and sleep is poorly understood to date.
Furthermore, studies looking at the effects of rocking on sleep have not yet been performed in an elderly population.
Due to age related changes in sleep, people often experience a decrease in sleep efficiency and sleep quality later in life.
Therefore, it is particularly this population that could benefit from a possible enhancement in sleep efficiency and sleep quality.
In order to assess the effect of vestibular stimulation on sleep and sleep-dependant memory, measurements of two nights with stimulation will be compared to two baseline nights.
The primary outcomes are changes in sleep onset, sleep architecture and power density spectra of the EEG due to vestibular stimulation.
Secondary endpoints are sleep dependent changes in memory, the proximal-distal temperature gradient, cardiorespiratory variables and dream content.
研究概览
研究类型
介入性
注册 (实际的)
19
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Zurich、瑞士、8092
- Sensory Motor Systems Lab
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
60年 至 75年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Right handed
- Between 60 and 75 years of age
Exclusion Criteria:
- Diseases or lesions of the nervous system (acute or residual included neurological and psychiatric diseases)
- BMI < 19 or > 30 kg/m2
- Medication known to influence sleep [56]
- Cognitive Impairment (MoCA score < 26)
- Drug use and abuse
- Nicotine use (e.g. smoking)
- > 10 alcoholic drinks per week
- > 5 drinks or foods containing caffeine per day
- History of sleep disorder (Insomnia, sleep apnea (apnea-hypopnea index >5), nocturnal myoclonus (>5 periodic leg movements per hour of sleep))
- Irregular sleep-wake rhythm (e.g. shift working)
- Travelling across time zones less than 1 month ago
- Naps longer than 1h
- Sleep on an average night <6 hours or >8 hours
- Skin allergies or very sensitive skin
- Diseases of the vestibular system
- Signs of motion sickness based on questionnaire
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：Baseline Nights
No vestibular stimulation is applied.
However, the sound of the moving bed will be played back to the participant at the right sound intensity level.
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实验性的：Movement Nights
Vestibular stimulation, in the form of gentle rocking movements, is provided using the Somnomat V4 rocking bed.
Stimulation is provided for the entire 7 hours of the night from lights off to lights on.
The stimulation frequency is in the range of 0.1-0.3
Hz, with an amplitude in the range of 0.05 to 0.1m
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Vestibular stimulation is provided using an innervated bed platform.
This robotic device consists of a standard single bed, mounted on a moving mechanism.
It was developed and produced by the ETH Zürich and approved for use in this study by Swissmedic.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Polysomnography
大体时间：4 nights of 7 hours each
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Difference in sleep parameters between the second of two nights with intervention and the second of two nights without intervention, as recorded using polysomnography. The sleep stages will be scored visually on a 20-s epoch basis according to standard criteria [53]. This will allow us to compare sleep architecture of the participants in the two conditions, as well as a possible consecutive nights effect in the two movement nights. Parameters of specific interest are sleep onset latency, total sleep time, time spent in N1, N2 and N3 stages of NREM sleep and time spent in REM sleep. Furthermore, the EEG power density spectra will be analysed. Power in specific frequency bands will be calculated based on spectral analysis, the amount and density of sleep spindles and slow waves will be determined. |
4 nights of 7 hours each
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Memory performance
大体时间：Recall moment in evening and morning (4 nights)
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Difference in declarative memory performance between the second of two nights with intervention and the second of two nights without intervention.
During each experimental night a word-pair recall task will be performed 1h before going to bed and half an hour after waking up.
To assess declarative memory performance improvement, we will determine the difference between immediate and delayed recall.
Word-pair recall tasks are suitable to determine declarative memory performance in the context of sleep, as they are sensitive to effects of sleep.
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Recall moment in evening and morning (4 nights)
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Skin temperature
大体时间：4 nights of 7 hours each
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The distal-proximal temperature gradient will be calculated, based on skin temperature measured using sensors placed on the chest and hands, to look for a relationship with sleep onset latency.
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4 nights of 7 hours each
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Robert Riener, Prof.、University of Zurich
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年11月12日
初级完成 (实际的)
2018年11月30日
研究完成 (实际的)
2018年11月30日
研究注册日期
首次提交
2017年4月5日
首先提交符合 QC 标准的
2017年4月27日
首次发布 (实际的)
2017年4月28日
研究记录更新
最后更新发布 (实际的)
2019年8月8日
上次提交的符合 QC 标准的更新
2019年8月7日
最后验证
2019年8月1日
更多信息
与本研究相关的术语
其他研究编号
- SOMNOMAT V4
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Somnomat V4的临床试验
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Assistance Publique Hopitaux De MarseilleAix Marseille Université; UMR 5203, InsermU1191, IGF, Montpellier; CRMBM-CEMEREM尚未招聘
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Andrei IagaruNational Cancer Institute (NCI); National Institutes of Health (NIH)完全的
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Jonsson Comprehensive Cancer CenterVarian Medical Systems招聘中