Vestibular Stimulation in Sleep for Neurorehabilitation Patients
16 giugno 2026 aggiornato da: 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
Panoramica dello studio
Stato
Non ancora reclutamento
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
20
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Polina Pchelina, Ph.D
- Numero di telefono: +41795765987
- Email: polina.pchelina@cereneo.ch
Luoghi di studio
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Weggis, Svizzera, 6353
- cereneo Schweiz AG, Hertensteinstrasse 162 CH-6353
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Contatto:
- Polina Pchelina
- Numero di telefono: +41795765987
- Email: polina.pchelina@cereneo.ch
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-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Objective total sleep time (TST)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
objective sleep efficiency (SE)
Lasso di tempo: 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.
|
|
objective sleep latency (SL)
Lasso di tempo: 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.
|
|
objective wake after sleep onset (WASO)
Lasso di tempo: 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)
Lasso di tempo: 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 number of awakenings
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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 %
|
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
Lasso di tempo: 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 N2
Lasso di tempo: 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 %
|
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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Age
Lasso di tempo: 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
|
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Gender
Lasso di tempo: 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
Lasso di tempo: 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
|
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Years of education
Lasso di tempo: 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
|
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Main diagnosis
Lasso di tempo: 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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Disease onset
Lasso di tempo: 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
|
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comorbid sleep disordes
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
3 agosto 2026
Completamento primario (Stimato)
31 luglio 2027
Completamento dello studio (Stimato)
31 dicembre 2027
Date di iscrizione allo studio
Primo inviato
7 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
16 giugno 2026
Primo Inserito (Effettivo)
18 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
18 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
16 giugno 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Disturbi cerebrovascolari
- Malattie del cervello
- Malattie del sistema nervoso centrale
- Malattie del sistema nervoso
- Malattie vascolari
- Malattia cardiovascolare
- Ferite e lesioni
- Processi patologici
- Trauma craniocerebrale
- Trauma, sistema nervoso
- Lesioni cerebrali
- Condizioni patologiche, segni e sintomi
- Lesioni cerebrali, traumatiche
- Ictus
- Degenerazione nervosa
Altri numeri di identificazione dello studio
- SOMNOMAT 2026-06
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano IPD
There is not a plan to make IPD available
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .