Vestibular Stimulation in Sleep for Neurorehabilitation Patients
2026년 6월 16일 업데이트: 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
연구 개요
상태
아직 모집하지 않음
연구 유형
중재적
등록 (추정된)
20
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Polina Pchelina, Ph.D
- 전화번호: +41795765987
- 이메일: polina.pchelina@cereneo.ch
연구 장소
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Weggis, 스위스, 6353
- cereneo Schweiz AG, Hertensteinstrasse 162 CH-6353
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연락하다:
- Polina Pchelina
- 전화번호: +41795765987
- 이메일: polina.pchelina@cereneo.ch
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-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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실험적: Group 2
Participants of Group 2 will be using the rocking bed in weeks 3-4 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Objective total sleep time (TST)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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objective sleep efficiency (SE)
기간: 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 sleep latency (SL)
기간: 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 wake after sleep onset (WASO)
기간: 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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total time in bed (TIB)
기간: 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
기간: 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
기간: 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
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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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proportion of N1
기간: 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
기간: 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
기간: 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
기간: 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 N3 stage
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
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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 total sleep time
기간: 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
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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 number of awakenings
기간: 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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subjective wake after sleep onset (WASO)
기간: 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
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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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PSQI score
기간: 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
기간: 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
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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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Age
기간: 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
기간: Collected at baseline (Week 0) between 03.08.2026 and 31.07.2027
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Collected at baseline (Week 0) between 03.08.2026 and 31.07.2027
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Race
기간: Collected at baseline (Week 0) between 03.08.2026 and 31.07.2027
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categorical variable
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Collected at baseline (Week 0) between 03.08.2026 and 31.07.2027
|
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Years of education
기간: 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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Main diagnosis
기간: 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
기간: Collected once at baseline (Week 0) between 03.08.2026 and 31.07.2027
|
years ago
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Collected once at baseline (Week 0) between 03.08.2026 and 31.07.2027
|
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comorbid sleep disordes
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 8월 3일
기본 완료 (추정된)
2027년 7월 31일
연구 완료 (추정된)
2027년 12월 31일
연구 등록 날짜
최초 제출
2026년 6월 7일
QC 기준을 충족하는 최초 제출
2026년 6월 16일
처음 게시됨 (실제)
2026년 6월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 16일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- SOMNOMAT 2026-06
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
There is not a plan to make IPD available
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .