Vestibular Stimulation in Sleep for Neurorehabilitation Patients
2026年6月16日 更新者：Cereneo AG
- Why are we conducting this study? You are a patient of the neurorehabilitation clinic with one of the therapy focuses on memory and learning. Neuropsychological training is a standard therapeutic approach in this case. It is also known that better quality of sleep may not only improve the well-being of individuals but also enhance memory and learning. In this study, we investigate how the rocking bed influences sleep duration and quality, whether it has additional effects on memory and learning, and if it is well-tolerated and safe.
What do you have to do if you decide to participate?
Participation in this study will take 4-6 weeks depending on your group. All study assess-ments will be done during your stay in the clinic. If you agree to participate, you will be asked to:
- Undergo an overnight sleep assessment (polysomnography) 3 or 4 times during the study, depending on the group you are allocated
- Sleep in the rocking bed for 14 consecutive nights
- Answer questionnaires related to your sleep If you decide to participate, you will be randomly assigned to one of 2 groups. Participants of Group 1 will be asked to use the rocking bed for the first 2 weeks after randomization. Participants of Group 2 will be using the rocking bed in weeks 3-4 after randomization.
- What are the benefits and risks associated with participation? Benefits Based on the previous studies of the rocking bed, it may improve your sleep quality and cognitive function. However, since its effectiveness for neurorehabilitation patients has not yet been established, any individual benefit cannot be guaranteed. It is possible that you will help future neurorehabilitation patients with your participation by generating data on the effectiveness and safety of the rocking bed in long-term use.
Risks
The investigational rocking bed has not yet been certified in Switzerland. Its use for neurorehabilitation patients is new and has not yet been tested. We may not yet know all the possible risks and side effects of the tested device. So far, the following risks and discomforts should be considered:
- A small risk of falling when getting out of bed at night
- Risk of unauthorized personal data access
- Temporary discomfort due to the study environment or equipment
研究概览
地位
尚未招聘
研究类型
介入性
注册 (估计的)
20
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。
学习联系方式
- 姓名：Polina Pchelina, Ph.D
- 电话号码：+41795765987
- 邮箱：polina.pchelina@cereneo.ch
学习地点
-
-
-
Weggis、瑞士、6353
- cereneo Schweiz AG, Hertensteinstrasse 162 CH-6353
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接触：
- Polina Pchelina
- 电话号码：+41795765987
- 邮箱：polina.pchelina@cereneo.ch
-
-
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
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Neurorehabilitation clinic patients with focus in learning or memory in neuropsychological training
- Age > 18 years
- Signed informed consent
- Smokers and non-smokers
- Patients of all ethnical backgrounds
Exclusion Criteria:
- Disorders of the vestibular system or sensitivity to motion sickness (Motion Sickness Susceptibility Questionnaire <10 (Golding, 2006)
- Hygiene-relevant infections requiring sanitization of patient care equipment: active or their asymptomatic carrying (as surface material of the rocking bed is not eligible
- Cognitive or motor deficit presenting a risk for self-use of the rocking bed at night: utmostly, creating the risk of falls during embarking and disembarking from the bed
- Transfer deficits. >1 persons are needed for transfer
- Short planned duration of stay <4 weeks
- Pregnancy or lactation
- Refusal to participate
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：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Group 1
Participants of Group 1 will be using the rocking bed for the first 2 weeks after randomization.
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Rocking is known to have a sedative and sleep-promoting effect: parents are rocking their newborns and infants to facilitate sleep, and many individuals experience increased sleepiness during passive motion, such as in transport.
Recent engineering solutions have enabled the development of rocking beds and wearable devices simulating motion.
Previous studies of rocking bed in healthy humans have shown that the use of these devices can improve sleep.
Furthermore, improvement of sleep can mediate positive effects of rocking on memory, learning.
However, their safety, effectiveness and applicability should be tested in research and clinical setting In this study, we are therefore investigating whether the rocking bed is efficient for sleep, if it has complementary effects on memory while using together with the cognitive training.
In addition we are testing, if the device is well tolerated.
The investigational device is not yet approved in Switzerland.
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实验性的：Group 2
Participants of Group 2 will be using the rocking bed in weeks 3-4 after randomization
|
Rocking is known to have a sedative and sleep-promoting effect: parents are rocking their newborns and infants to facilitate sleep, and many individuals experience increased sleepiness during passive motion, such as in transport.
Recent engineering solutions have enabled the development of rocking beds and wearable devices simulating motion.
Previous studies of rocking bed in healthy humans have shown that the use of these devices can improve sleep.
Furthermore, improvement of sleep can mediate positive effects of rocking on memory, learning.
However, their safety, effectiveness and applicability should be tested in research and clinical setting In this study, we are therefore investigating whether the rocking bed is efficient for sleep, if it has complementary effects on memory while using together with the cognitive training.
In addition we are testing, if the device is well tolerated.
The investigational device is not yet approved in Switzerland.
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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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Objective total sleep time (TST)
大体时间：Objective sleep measures (PSG) are obtained pre- and post-intervention phases at follow up: Week 0, Week 2, Week 4 for Groups 1 and 2; Week 6 for Group 2.
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measured with polysomnography
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Objective sleep measures (PSG) are obtained pre- and post-intervention phases at follow up: Week 0, Week 2, Week 4 for Groups 1 and 2; Week 6 for Group 2.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
objective sleep efficiency (SE)
大体时间：Objective sleep measures (PSG) are obtained pre- and post-intervention phases at follow up: Week 0, Week 2, Week 4 for Groups 1 and 2; Week 6 for Group 2.
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measured by PSG
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Objective sleep measures (PSG) are obtained pre- and post-intervention phases at follow up: Week 0, Week 2, Week 4 for Groups 1 and 2; Week 6 for Group 2.
|
|
objective sleep latency (SL)
大体时间：Objective sleep measures (PSG) are obtained pre- and post-intervention phases at follow up: Week 0, Week 2, Week 4 for Groups 1 and 2; Week 6 for Group 2.
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measured by PSG
|
Objective sleep measures (PSG) are obtained pre- and post-intervention phases at follow up: Week 0, Week 2, Week 4 for Groups 1 and 2; Week 6 for Group 2.
|
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objective wake after sleep onset (WASO)
大体时间：Objective sleep measures (PSG) are obtained pre- and post-intervention phases at follow up: Week 0, Week 2, Week 4 for Groups 1 and 2; Week 6 for Group 2.
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measured by PSG
|
Objective sleep measures (PSG) are obtained pre- and post-intervention phases at follow up: Week 0, Week 2, Week 4 for Groups 1 and 2; Week 6 for Group 2.
|
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total time in bed (TIB)
大体时间：Objective sleep measures (PSG) are obtained pre- and post-intervention phases at follow up: Week 0, Week 2, Week 4 for Groups 1 and 2; Week 6 for Group 2.
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measured by PSG
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Objective sleep measures (PSG) are obtained pre- and post-intervention phases at follow up: Week 0, Week 2, Week 4 for Groups 1 and 2; Week 6 for Group 2.
|
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Objective number of awakenings
大体时间：Objective sleep measures (PSG) are obtained pre- and post-intervention phases at follow up: Week 0, Week 2, Week 4 for Groups 1 and 2; Week 6 for Group 2.
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measured by PSG
|
Objective sleep measures (PSG) are obtained pre- and post-intervention phases at follow up: Week 0, Week 2, Week 4 for Groups 1 and 2; Week 6 for Group 2.
|
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absolute duration of N1
大体时间：Objective sleep measures (PSG) are obtained pre- and post-intervention phases at follow up: Week 0, Week 2, Week 4 for Groups 1 and 2; Week 6 for Group 2.
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obtained from PSG, measured in min
|
Objective sleep measures (PSG) are obtained pre- and post-intervention phases at follow up: Week 0, Week 2, Week 4 for Groups 1 and 2; Week 6 for Group 2.
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proportion of N1
大体时间：obtained pre- and post-intervention phases at follow up: Week 0, Week 2, Week 4 for Groups 1 and 2; Week 6 for Group 2.
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obtained from PSG, measured in %
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obtained pre- and post-intervention phases at follow up: Week 0, Week 2, Week 4 for Groups 1 and 2; Week 6 for Group 2.
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absolute duration of N2
大体时间：obtained between 03.08.2026 and 31.07.2027 at pre- and post-intervention phases and at follow up: Week 0, Week 2, Week 4 for Groups 1 and 2; Week 6 for Group 2.
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obtained from PSG, measured in min
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obtained between 03.08.2026 and 31.07.2027 at pre- and post-intervention phases and at follow up: Week 0, Week 2, Week 4 for Groups 1 and 2; Week 6 for Group 2.
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Proportion of N2
大体时间：obtained between 03.08.2026 and 31.07.2027 at pre- and post-intervention phases and at follow up: Week 0, Week 2, Week 4 for Groups 1 and 2; Week 6 for Group 2.
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obtained from PSG, measured in %
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obtained between 03.08.2026 and 31.07.2027 at pre- and post-intervention phases and at follow up: Week 0, Week 2, Week 4 for Groups 1 and 2; Week 6 for Group 2.
|
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absolute duration of N3 stage
大体时间：obtained between 03.08.2026 and 31.07.2027 at pre- and post-intervention phases and at follow up: Week 0, Week 2, Week 4 for Groups 1 and 2; Week 6 for Group 2.
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obtained from PSG, measured in min
|
obtained between 03.08.2026 and 31.07.2027 at pre- and post-intervention phases and at follow up: Week 0, Week 2, Week 4 for Groups 1 and 2; Week 6 for Group 2.
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Proportion of N3 stage
大体时间：obtained between 03.08.2026 and 31.07.2027 at pre- and post-intervention phases and at follow up: Week 0, Week 2, Week 4 for Groups 1 and 2; Week 6 for Group 2.
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obtained from PSG
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obtained between 03.08.2026 and 31.07.2027 at pre- and post-intervention phases and at follow up: Week 0, Week 2, Week 4 for Groups 1 and 2; Week 6 for Group 2.
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absolute duration of REM phase
大体时间：obtained between 03.08.2026 and 31.07.2027 at pre- and post-intervention phases and at follow up: Week 0, Week 2, Week 4 for Groups 1 and 2; Week 6 for Group 2.
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obtained from PSG, measured in min
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obtained between 03.08.2026 and 31.07.2027 at pre- and post-intervention phases and at follow up: Week 0, Week 2, Week 4 for Groups 1 and 2; Week 6 for Group 2.
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Proportion of REM phase
大体时间：obtained between 03.08.2026 and 31.07.2027 at pre- and post-intervention phases and at follow up: Week 0, Week 2, Week 4 for Groups 1 and 2; Week 6 for Group 2.
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obtained from PSG, measured in %
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obtained between 03.08.2026 and 31.07.2027 at pre- and post-intervention phases and at follow up: Week 0, Week 2, Week 4 for Groups 1 and 2; Week 6 for Group 2.
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Total number of sleep spindles
大体时间：obtained between 03.08.2026 and 31.07.2027 at pre- and post-intervention phases and at follow up: Week 0, Week 2, Week 4 for Groups 1 and 2; Week 6 for Group 2.
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obtained from PSG, countable variable
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obtained between 03.08.2026 and 31.07.2027 at pre- and post-intervention phases and at follow up: Week 0, Week 2, Week 4 for Groups 1 and 2; Week 6 for Group 2.
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Density of sleep spindles
大体时间：obtained between 03.08.2026 and 31.07.2027 at pre- and post-intervention phases and at follow up: Week 0, Week 2, Week 4 for Groups 1 and 2; Week 6 for Group 2.
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obtained from PSG, index calculated as number of events per 1 h in N2 stage
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obtained between 03.08.2026 and 31.07.2027 at pre- and post-intervention phases and at follow up: Week 0, Week 2, Week 4 for Groups 1 and 2; Week 6 for Group 2.
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Slow wave activity
大体时间：obtained between 03.08.2026 and 31.07.2027 at pre- and post-intervention phases and at follow up: Week 0, Week 2, Week 4 for Groups 1 and 2; Week 6 for Group 2.
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obtained from PSG, power of delta activity per unit of time
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obtained between 03.08.2026 and 31.07.2027 at pre- and post-intervention phases and at follow up: Week 0, Week 2, Week 4 for Groups 1 and 2; Week 6 for Group 2.
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subjective sleep effectiveness
大体时间：obtained between 03.08.2026 and 31.07.2027 at pre- and post-intervention phases and at follow up: Week 0-4 for Group 1 and Week 0-6 for Group 2.
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obtained from a daily sleep diary, measured in %
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obtained between 03.08.2026 and 31.07.2027 at pre- and post-intervention phases and at follow up: Week 0-4 for Group 1 and Week 0-6 for Group 2.
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subjective sleep latency
大体时间：obtained between 03.08.2026 and 31.07.2027 at pre- and post-intervention phases and at follow up: Week 0-4 for Group 1 and Week 0-6 for Group 2.
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obtained from daily sleep diary
|
obtained between 03.08.2026 and 31.07.2027 at pre- and post-intervention phases and at follow up: Week 0-4 for Group 1 and Week 0-6 for Group 2.
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subjective total sleep time
大体时间：obtained between 03.08.2026 and 31.07.2027 at pre- and post-intervention phases and at follow up: Week 0-4 for Group 1 and Week 0-6 for Group 2.
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obtained from daily sleep diary
|
obtained between 03.08.2026 and 31.07.2027 at pre- and post-intervention phases and at follow up: Week 0-4 for Group 1 and Week 0-6 for Group 2.
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Subjective number of awakenings
大体时间：obtained between 03.08.2026 and 31.07.2027 at pre- and post-intervention phases and at follow up: Week 0-4 for Group 1 and Week 0-6 for Group 2.
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obtained from daily sleep diary
|
obtained between 03.08.2026 and 31.07.2027 at pre- and post-intervention phases and at follow up: Week 0-4 for Group 1 and Week 0-6 for Group 2.
|
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subjective wake after sleep onset (WASO)
大体时间：obtained between 03.08.2026 and 31.07.2027 at pre- and post-intervention phases and at follow up: Week 0-4 for Group 1 and Week 0-6 for Group 2.
|
obtained from daily sleep diary
|
obtained between 03.08.2026 and 31.07.2027 at pre- and post-intervention phases and at follow up: Week 0-4 for Group 1 and Week 0-6 for Group 2.
|
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PSQI score
大体时间：subjective sleep quality are obtained between 03.08.2026 and 31.07.2027 at pre- and post-intervention phases and at follow up: Week 0, Week 2, Week 4 for Groups 1 and 2; Week 6 for Group 2.
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Pittsburgh Sleep Quality Index (PSQI), a validated self-report measure of sleep quality over the past month.
The PSQI yields a global score (0-21), with higher scores indicating poorer sleep quality.
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subjective sleep quality are obtained between 03.08.2026 and 31.07.2027 at pre- and post-intervention phases and at follow up: Week 0, Week 2, Week 4 for Groups 1 and 2; Week 6 for Group 2.
|
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Verbal memory
大体时间：obtained between 03.08.2026 and 31.07.2027 at pre- and post-intervention phases and at follow up: between Week 0 and Week 4 for Group 1 and between Week 0 and Week 6 for Group 2.
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Neuropsychological test: Auditiv-Verbaler Lern- und Gedächtnistest (AVLGT) for German-speaking participants, or its English adaptation, Verbal Learning and memory test (VLMT) the consisting of 15 words with different word lists in order to avoid learning effect.
Assessments are conducted weekly
|
obtained between 03.08.2026 and 31.07.2027 at pre- and post-intervention phases and at follow up: between Week 0 and Week 4 for Group 1 and between Week 0 and Week 6 for Group 2.
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Age
大体时间：Collected at baseline (Week 0) between 03.08.2026 and 31.07.2027
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measured in years
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Collected at baseline (Week 0) between 03.08.2026 and 31.07.2027
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Gender
大体时间：Collected at baseline (Week 0) between 03.08.2026 and 31.07.2027
|
Collected at baseline (Week 0) between 03.08.2026 and 31.07.2027
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|
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Race
大体时间：Collected at baseline (Week 0) between 03.08.2026 and 31.07.2027
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categorical variable
|
Collected at baseline (Week 0) between 03.08.2026 and 31.07.2027
|
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Years of education
大体时间：Collected at baseline (Week 0) between 03.08.2026 and 31.07.2027
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measured in years
|
Collected at baseline (Week 0) between 03.08.2026 and 31.07.2027
|
|
Main diagnosis
大体时间：Collected at baseline (Week 0) between 03.08.2026 and 31.07.2027
|
Collected at baseline (Week 0) between 03.08.2026 and 31.07.2027
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|
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Disease onset
大体时间：Collected once at baseline (Week 0) between 03.08.2026 and 31.07.2027
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years ago
|
Collected once at baseline (Week 0) between 03.08.2026 and 31.07.2027
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comorbid sleep disordes
大体时间：Collected at baseline (Week 0) between 03.08.2026 and 31.07.2027
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categorical variable
|
Collected at baseline (Week 0) between 03.08.2026 and 31.07.2027
|
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Medications
大体时间：Collected at baseline (Week 0) between 03.08.2026 and 31.07.2027
|
categorical variable
|
Collected at baseline (Week 0) between 03.08.2026 and 31.07.2027
|
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。
赞助
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 (估计的)
2026年8月3日
初级完成 (估计的)
2027年7月31日
研究完成 (估计的)
2027年12月31日
研究注册日期
首次提交
2026年6月7日
首先提交符合 QC 标准的
2026年6月16日
首次发布 (实际的)
2026年6月18日
研究记录更新
最后更新发布 (实际的)
2026年6月18日
上次提交的符合 QC 标准的更新
2026年6月16日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- SOMNOMAT 2026-06
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
There is not a plan to make IPD available
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.