CClinicalTrials.gg
Not yet recruitingNCT07658027Updated Jun 18, 2026

Vestibular Stimulation in Sleep for Neurorehabilitation Patients

An interventional study of Somnomat - rocking bed providing vestibular stimulation during sleep in Memory Deficit Aquired Due to the Disease, e.g. Stroke, Neurodegeneration, Inflammatory Disease of CNS, Traumatic Brain Injury, sponsored by Cereneo AG. Not yet recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-18.

Sponsored by Cereneo AG · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

  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
02

Conditions studied

  • Memory Deficit Aquired Due to the Disease, e.g. Stroke, Neurodegeneration, Inflammatory Disease of CNS, Traumatic Brain Injury

Keywords

  • stroke
  • neurodegeneration
  • inflammatory disease of CNS
  • traumatic brain injury
03

In context

Nerve Degeneration

132 studies on the registry are indexed under Nerve Degeneration; 54 are open to participants now.

This study's planned enrollment of 20 is below the median of 50 across 73 interventional studies indexed under Nerve Degeneration.

Browse Nerve Degeneration studies →

Lead sponsor

Cereneo AG is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Group 1

    Participants of Group 1 will be using the rocking bed for the first 2 weeks after randomization.

    Device: Somnomat - rocking bed providing vestibular stimulation during sleep

  • Experimental
    Group 2

    Participants of Group 2 will be using the rocking bed in weeks 3-4 after randomization

    Device: Somnomat - rocking bed providing vestibular stimulation during sleep

Interventions

  • DeviceSomnomat - 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.

06

What researchers measure

Primary outcomes

  1. Objective total sleep time (TST)

    measured with polysomnography

    Time frame: 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.

Secondary outcomes

  1. objective sleep efficiency (SE)

    measured by PSG

    Time frame: 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.

  2. objective sleep latency (SL)

    measured by PSG

    Time frame: 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.

  3. objective wake after sleep onset (WASO)

    measured by PSG

    Time frame: 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.

  4. total time in bed (TIB)

    measured by PSG

    Time frame: 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.

  5. Objective number of awakenings

    measured by PSG

    Time frame: 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.

  6. absolute duration of N1

    obtained from PSG, measured in min

    Time frame: 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.

  7. proportion of N1

    obtained from PSG, measured in %

    Time frame: 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.

  8. absolute duration of N2

    obtained from PSG, measured in min

    Time frame: 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.

  9. Proportion of N2

    obtained from PSG, measured in %

    Time frame: 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.

  10. absolute duration of N3 stage

    obtained from PSG, measured in min

    Time frame: 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.

  11. Proportion of N3 stage

    obtained from PSG

    Time frame: 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.

  12. absolute duration of REM phase

    obtained from PSG, measured in min

    Time frame: 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.

  13. Proportion of REM phase

    obtained from PSG, measured in %

    Time frame: 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.

  14. Total number of sleep spindles

    obtained from PSG, countable variable

    Time frame: 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.

  15. Density of sleep spindles

    obtained from PSG, index calculated as number of events per 1 h in N2 stage

    Time frame: 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.

  16. Slow wave activity

    obtained from PSG, power of delta activity per unit of time

    Time frame: 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.

  17. subjective sleep effectiveness

    obtained from a daily sleep diary, measured in %

    Time frame: 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.

  18. subjective sleep latency

    obtained from daily sleep diary

    Time frame: 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.

  19. subjective total sleep time

    obtained from daily sleep diary

    Time frame: 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.

  20. Subjective number of awakenings

    obtained from daily sleep diary

    Time frame: 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.

  21. subjective wake after sleep onset (WASO)

    obtained from daily sleep diary

    Time frame: 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.

  22. PSQI score

    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.

    Time frame: 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.

  23. Verbal memory

    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

    Time frame: 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.

Other outcomes

  1. Age

    measured in years

    Time frame: Collected at baseline (Week 0) between 03.08.2026 and 31.07.2027

  2. Gender

    Time frame: Collected at baseline (Week 0) between 03.08.2026 and 31.07.2027

  3. Race

    categorical variable

    Time frame: Collected at baseline (Week 0) between 03.08.2026 and 31.07.2027

  4. Years of education

    measured in years

    Time frame: Collected at baseline (Week 0) between 03.08.2026 and 31.07.2027

  5. Main diagnosis

    Time frame: Collected at baseline (Week 0) between 03.08.2026 and 31.07.2027

  6. Disease onset

    years ago

    Time frame: Collected once at baseline (Week 0) between 03.08.2026 and 31.07.2027

  7. comorbid sleep disordes

    categorical variable

    Time frame: Collected at baseline (Week 0) between 03.08.2026 and 31.07.2027

  8. Medications

    categorical variable

    Time frame: Collected at baseline (Week 0) between 03.08.2026 and 31.07.2027

07

Study locations

1 site
  • cereneo Schweiz AG, Hertensteinstrasse 162 CH-6353
    Weggis, 6353, Switzerland
08

References and documents

Individual participant data

Plan to share: No — There is not a plan to make IPD available

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07658027
Lead sponsor
Cereneo AG
Responsible party
Sponsor
First posted
Jun 18, 2026
Start date
Aug 3, 2026 (estimated)
Primary completion
Jul 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Jun 18, 2026

Study contacts

Polina Pchelina, Ph.D
Contact
polina.pchelina@cereneo.ch
+41795765987

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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