Vestibular Stimulation in Sleep for Neurorehabilitation Patients
16 czerwca 2026 zaktualizowane przez: 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
Przegląd badań
Status
Jeszcze nie rekrutacja
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Szacowany)
20
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Polina Pchelina, Ph.D
- Numer telefonu: +41795765987
- E-mail: polina.pchelina@cereneo.ch
Lokalizacje studiów
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-
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Weggis, Szwajcaria, 6353
- cereneo Schweiz AG, Hertensteinstrasse 162 CH-6353
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Kontakt:
- Polina Pchelina
- Numer telefonu: +41795765987
- E-mail: polina.pchelina@cereneo.ch
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Group 1
Participants of Group 1 will be using the rocking bed for the first 2 weeks 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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Eksperymentalny: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Objective total sleep time (TST)
Ramy czasowe: 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.
|
measured with polysomnography
|
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.
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
objective sleep efficiency (SE)
Ramy czasowe: 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.
|
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.
|
|
objective sleep latency (SL)
Ramy czasowe: 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.
|
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.
|
|
objective wake after sleep onset (WASO)
Ramy czasowe: 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.
|
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.
|
|
total time in bed (TIB)
Ramy czasowe: 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.
|
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.
|
|
Objective number of awakenings
Ramy czasowe: 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.
|
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.
|
|
absolute duration of N1
Ramy czasowe: 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.
|
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.
|
|
proportion of N1
Ramy czasowe: 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.
|
obtained from PSG, measured in %
|
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.
|
|
absolute duration of N2
Ramy czasowe: 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.
|
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.
|
|
Proportion of N2
Ramy czasowe: 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.
|
obtained from PSG, measured in %
|
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
Ramy czasowe: 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.
|
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
Ramy czasowe: 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
|
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
Ramy czasowe: 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.
|
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 REM phase
Ramy czasowe: 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.
|
obtained from PSG, measured in %
|
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
Ramy czasowe: 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
|
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
Ramy czasowe: 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.
|
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.
|
|
Slow wave activity
Ramy czasowe: 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.
|
obtained from PSG, power of delta activity per unit of time
|
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.
|
|
subjective sleep effectiveness
Ramy czasowe: 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 a daily sleep diary, measured in %
|
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.
|
|
subjective sleep latency
Ramy czasowe: 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.
|
|
subjective total sleep time
Ramy czasowe: 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.
|
|
Subjective number of awakenings
Ramy czasowe: 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.
|
|
subjective wake after sleep onset (WASO)
Ramy czasowe: 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.
|
|
PSQI score
Ramy czasowe: 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.
|
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
Ramy czasowe: 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.
|
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.
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Age
Ramy czasowe: Collected at baseline (Week 0) between 03.08.2026 and 31.07.2027
|
measured in years
|
Collected at baseline (Week 0) between 03.08.2026 and 31.07.2027
|
|
Gender
Ramy czasowe: 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
|
|
|
Race
Ramy czasowe: 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
|
|
Years of education
Ramy czasowe: Collected at baseline (Week 0) between 03.08.2026 and 31.07.2027
|
measured in years
|
Collected at baseline (Week 0) between 03.08.2026 and 31.07.2027
|
|
Main diagnosis
Ramy czasowe: 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
|
|
|
Disease onset
Ramy czasowe: Collected once at baseline (Week 0) between 03.08.2026 and 31.07.2027
|
years ago
|
Collected once at baseline (Week 0) between 03.08.2026 and 31.07.2027
|
|
comorbid sleep disordes
Ramy czasowe: 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
|
|
Medications
Ramy czasowe: 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
|
Współpracownicy i badacze
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Sponsor
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
3 sierpnia 2026
Zakończenie podstawowe (Szacowany)
31 lipca 2027
Ukończenie studiów (Szacowany)
31 grudnia 2027
Daty rejestracji na studia
Pierwszy przesłany
7 czerwca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
16 czerwca 2026
Pierwszy wysłany (Rzeczywisty)
18 czerwca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
18 czerwca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
16 czerwca 2026
Ostatnia weryfikacja
1 czerwca 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Zaburzenia naczyniowo-mózgowe
- Choroby mózgu
- Choroby ośrodkowego układu nerwowego
- Choroby Układu Nerwowego
- Choroby naczyniowe
- Choroby układu krążenia
- Rany i urazy
- Procesy patologiczne
- Uraz czaszkowo-mózgowy
- Uraz, układ nerwowy
- Urazy mózgu
- Stany patologiczne, oznaki i objawy
- Urazy mózgu, traumatyczne
- Uderzenie
- Degeneracja nerwów
Inne numery identyfikacyjne badania
- SOMNOMAT 2026-06
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Opis planu IPD
There is not a plan to make IPD available
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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