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NCT Number: NCT07658027

Vestibular Stimulation in Sleep for Neurorehabilitation Patients

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

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Key information

Conditions

Memory Deficit Aquired Due to the Disease, e.g. Stroke, Neurodegeneration, Inflammatory Disease of CNS, Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Nerve Degeneration Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

cereneo Schweiz AG, Hertensteinstrasse 162 CH-6353

Weggis, 6353, Switzerland

Location contact

Polina Pchelina

CONTACT

[email protected]

+41795765987

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Somnomat - rocking bed providing vestibular stimulation during sleep

Device

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.

Primary outcomes

  1. 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.

    measured with polysomnography

Secondary outcomes

  1. objective sleep efficiency (SE)

    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.

    measured by PSG

  2. objective sleep latency (SL)

    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.

    measured by PSG

  3. objective wake after sleep onset (WASO)

    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.

    measured by PSG

  4. total time in bed (TIB)

    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.

    measured by PSG

  5. Objective number of awakenings

    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.

    measured by PSG

  6. absolute duration of N1

    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.

    obtained from PSG, measured in min

  7. proportion of N1

    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.

    obtained from PSG, measured in %

  8. absolute duration of N2

    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.

    obtained from PSG, measured in min

  9. Proportion of N2

    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.

    obtained from PSG, measured in %

  10. absolute duration of N3 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.

    obtained from PSG, measured in min

  11. Proportion of N3 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.

    obtained from PSG

  12. absolute duration of REM phase

    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.

    obtained from PSG, measured in min

  13. Proportion of REM phase

    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.

    obtained from PSG, measured in %

  14. Total number of sleep spindles

    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.

    obtained from PSG, countable variable

  15. Density of sleep spindles

    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.

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

  16. Slow wave activity

    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.

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

  17. subjective sleep effectiveness

    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.

    obtained from a daily sleep diary, measured in %

  18. subjective sleep latency

    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.

    obtained from daily sleep diary

  19. subjective total sleep time

    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.

    obtained from daily sleep diary

  20. Subjective number of awakenings

    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.

    obtained from daily sleep diary

  21. subjective wake after sleep onset (WASO)

    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.

    obtained from daily sleep diary

  22. PSQI score

    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.

    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.

  23. Verbal memory

    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.

    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

Other outcomes

  1. Age

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

    measured in years

  2. Gender

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

  3. Race

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

    categorical variable

  4. Years of education

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

    measured in years

  5. Main diagnosis

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

  6. Disease onset

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

    years ago

  7. comorbid sleep disordes

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

    categorical variable

  8. Medications

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

    categorical variable

Study contacts

Contact information is provided by the study sponsor or research team.

Polina Pchelina, Ph.D

CONTACT

[email protected]

+41795765987

Sponsors and collaborators

Lead sponsor

Cereneo AG

Industry

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 18, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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