Vestibular Stimulation in Sleep for Neurorehabilitation Patients

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

Conditions

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

Interventions

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.

Sponsors & Collaborators

• Cereneo AG

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-03

Primary Completion

2027-07-31

Completion

2027-12-31

Countries

• Switzerland

Study Locations