Vestibular Stimulation in Sleep for Neurorehabilitation Patients

N/ANot Yet RecruitingNCT07658027

Cereneo AG20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Objective total sleep time (TST)

measured with polysomnography

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.

Secondary Outcomes

objective sleep efficiency (SE)

measured by PSG

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.

objective sleep latency (SL)

measured by PSG

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.

objective wake after sleep onset (WASO)

measured by PSG

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.

total time in bed (TIB)

measured by PSG

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.

Objective number of awakenings

measured by PSG

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.

absolute duration of N1

obtained from PSG, measured in min

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.

proportion of N1

obtained from PSG, measured in %

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.

absolute duration of N2

obtained from PSG, measured in min