Vestibular Stimulation in Sleep for Neurorehabilitation Patients
16. Juni 2026 aktualisiert von: 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
Studienübersicht
Status
Noch keine Rekrutierung
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Geschätzt)
20
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Polina Pchelina, Ph.D
- Telefonnummer: +41795765987
- E-Mail: polina.pchelina@cereneo.ch
Studienorte
-
-
-
Weggis, Schweiz, 6353
- cereneo Schweiz AG, Hertensteinstrasse 162 CH-6353
-
Kontakt:
- Polina Pchelina
- Telefonnummer: +41795765987
- E-Mail: polina.pchelina@cereneo.ch
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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.
|
|
Experimental: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Objective total sleep time (TST)
Zeitfenster: 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.
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
objective sleep efficiency (SE)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
|
|
absolute duration of N3 stage
Zeitfenster: 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 N3 stage
Zeitfenster: 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
|
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.
|
|
absolute duration of REM phase
Zeitfenster: 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 REM phase
Zeitfenster: 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.
|
|
Total number of sleep spindles
Zeitfenster: 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, 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
Zeitfenster: 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
|
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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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.
|
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
Zeitfenster: 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.
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Age
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
3. August 2026
Primärer Abschluss (Geschätzt)
31. Juli 2027
Studienabschluss (Geschätzt)
31. Dezember 2027
Studienanmeldedaten
Zuerst eingereicht
7. Juni 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
16. Juni 2026
Zuerst gepostet (Tatsächlich)
18. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
18. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
16. Juni 2026
Zuletzt verifiziert
1. Juni 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Zerebrovaskuläre Erkrankungen
- Erkrankungen des Gehirns
- Erkrankungen des zentralen Nervensystems
- Erkrankungen des Nervensystems
- Gefäßerkrankungen
- Herz-Kreislauf-Erkrankungen
- Wunden und Verletzungen
- Pathologische Prozesse
- Kraniozerebrales Trauma
- Trauma, Nervensystem
- Hirnverletzungen
- Pathologische Zustände, Anzeichen und Symptome
- Hirnverletzungen, traumatisch
- Streicheln
- Nervendegeneration
Andere Studien-ID-Nummern
- SOMNOMAT 2026-06
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Beschreibung des IPD-Plans
There is not a plan to make IPD available
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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