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

Study Overview

• Status: Not yet recruiting
• Conditions: Memory Deficit Aquired Due to the Disease, e.g. Stroke, Neurodegeneration, Inflammatory Disease of CNS, Traumatic Brain Injury
• Intervention / Treatment: Device: Somnomat - rocking bed providing vestibular stimulation during sleep

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Polina Pchelina, Ph.D; Phone Number: +41795765987; Email: polina.pchelina@cereneo.ch

Study Locations

• Switzerland
  • Weggis, Switzerland, 6353
    • cereneo Schweiz AG, Hertensteinstrasse 162 CH-6353
    • Contact: Polina Pchelina; Phone Number: +41795765987; Email: polina.pchelina@cereneo.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective total sleep time (TST)	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
objective sleep efficiency (SE)	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)	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)	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)	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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)	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	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	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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	measured in years	Collected at baseline (Week 0) between 03.08.2026 and 31.07.2027
Gender		Collected at baseline (Week 0) between 03.08.2026 and 31.07.2027
Race	categorical variable	Collected at baseline (Week 0) between 03.08.2026 and 31.07.2027
Years of education	measured in years	Collected at baseline (Week 0) between 03.08.2026 and 31.07.2027
Main diagnosis		Collected at baseline (Week 0) between 03.08.2026 and 31.07.2027
Disease onset	years ago	Collected once at baseline (Week 0) between 03.08.2026 and 31.07.2027
comorbid sleep disordes	categorical variable	Collected at baseline (Week 0) between 03.08.2026 and 31.07.2027
Medications	categorical variable	Collected at baseline (Week 0) between 03.08.2026 and 31.07.2027

Collaborators and Investigators

• Sponsor: Cereneo AG

Study record dates

Study Major Dates

• Study Start (Estimated): August 3, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: June 7, 2026
• First Submitted That Met QC Criteria: June 16, 2026
• First Posted (Actual): June 18, 2026

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: stroke; neurodegeneration; traumatic brain injury; inflammatory disease of CNS
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Pathological Conditions, Signs and Symptoms; Brain Injuries, Traumatic; Stroke; Nerve Degeneration
• Other Study ID Numbers: SOMNOMAT 2026-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No