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Memory Deficit Aquired Due to the Disease, e.g. Stroke, Neurodegeneration, Inflammatory Disease of CNS, Traumatic Brain InjuryNCT07658027

Vestibular Stimulation in Sleep for Neurorehabilitation Patients

A study testing Somnomat - rocking bed providing vestibular stimulation during sleep in people with Memory Deficit Aquired Due to the Disease, e.g. Stroke, Neurodegeneration, Inflammatory Disease of CNS, Traumatic Brain Injury, run by Cereneo AG at 1 site in Switzerland.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Somnomat - rocking bed providing vestibular stimulation during sleep
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSwitzerland
Study dates
3 Feb 2027to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Polina Pchelina, Ph.D contact

+41795765987

polina.pchelina@cereneo.ch

Switzerland1 site
  • cereneo Schweiz AG, Hertensteinstrasse 162 CH-6353

    Weggis, 6353

    Polina Pchelina, +41795765987, polina.pchelina@cereneo.ch

Other trials in Switzerland

About this study

  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.
Read more
  1. 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
Being tested
Somnomat - rocking bed providing vestibular stimulation during sleep
Keywords
stroke, neurodegeneration, inflammatory disease of CNS, traumatic brain injury
Medical subject headings
Nerve Degeneration, Brain Injuries, Traumatic, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Somnomat - rocking bed providing vestibular stimulation during sleepDevice

    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.

Study groups in NCT07658027
Study groupRoleWhat they receive
Group 1ExperimentalParticipants of Group 1 will be using the rocking bed for the first 2 weeks after randomization.
Receives: Device: Somnomat - rocking bed providing vestibular stimulation during sleep
Group 2ExperimentalParticipants of Group 2 will be using the rocking bed in weeks 3-4 after randomization
Receives: Device: Somnomat - rocking bed providing vestibular stimulation during sleep

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective total sleep time (TST)

    measured with polysomnography

    Measured: 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 (23)
  1. objective sleep efficiency (SE)

    measured by PSG

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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 %

    Measured: 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

    Measured: 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 %

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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 %

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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 %

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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.

    Measured: 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

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2026
  2. Study start3 Feb 2027 (estimated)
  3. Primary completion29 Feb 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07658027
Sponsor's protocol ID
SOMNOMAT 2026-06
Status last verified
Jun 2026
First submitted
7 Jun 2026
Last updated
3 Nov 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is not a plan to make IPD available

Questions about this trial

What is this clinical trial studying?

A study testing Somnomat - rocking bed providing vestibular stimulation during sleep in people with Memory Deficit Aquired Due to the Disease, e.g. Stroke, Neurodegeneration, Inflammatory Disease of CNS, Traumatic Brain Injury, run by Cereneo AG at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Polina Pchelina, Ph.D (+41795765987, polina.pchelina@cereneo.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective total sleep time (TST) (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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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