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Vestibular Stimulation in Sleep for Neurorehabilitation Patients

16 juni 2026 bijgewerkt door: Cereneo AG
  1. 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.

  2. 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.
  3. 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

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

20

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Group 1
Participants of Group 1 will be using the rocking bed for the first 2 weeks after randomization.
Apparaat: Somnomat - rocking bed providing vestibular stimulation during sleep
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.
Experimenteel: Group 2
Participants of Group 2 will be using the rocking bed in weeks 3-4 after randomization
Apparaat: Somnomat - rocking bed providing vestibular stimulation during sleep
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Objective total sleep time (TST)
Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
objective sleep efficiency (SE)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
Density of sleep spindles
Tijdsspanne: 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
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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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.
Verbal memory
Tijdsspanne: 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 uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Age
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Cereneo AG

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

3 augustus 2026

Primaire voltooiing (Geschat)

31 juli 2027

Studie voltooiing (Geschat)

31 december 2027

Studieregistratiedata

Eerst ingediend

7 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

16 juni 2026

Eerst geplaatst (Werkelijk)

18 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

18 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

16 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • SOMNOMAT 2026-06

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

There is not a plan to make IPD available

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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