← Back to all trials
Not Yet Recruiting
NCT07658027
Vestibular Stimulation in Sleep for Neurorehabilitation Patients
Conditions: Memory Deficit Aquired Due to the Disease, e.g. Stroke, Neurodegeneration, Inflammatory Disease of CNS, Traumatic Brain Injury
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 20
Sponsor: Cereneo AG
Location: cereneo Schweiz AG, Hertensteinstrasse 162 CH-6353 Weggis
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
Eligibility Criteria
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 \1 persons are needed for transfer
* Short planned duration of stay \
Source: ClinicalTrials.gov (NCT07658027). StuddyBuddy aggregates publicly available trial information.