NCT07658027

Vestibular Stimulation in Sleep for Neurorehabilitation Patients

StatusNot Yet Recruiting

PhaseNot applicable

SponsorCereneo AG

Primary completionFeb 29, 2028 (estimated)

At risk: Primary completion moved at least 7 months later.

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Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

Notable Oct 30, 2026 Primary completion pushed from Jul 31, 2027 to Feb 29, 2028 Show 4 more changesShow less
- Start date: Aug 3, 2026 to Feb 3, 2027
- Study completion pushed from Dec 31, 2027 to Dec 31, 2028
- Eligibility criteria expanded, about 12 words
- Secondary endpoints: details revised at 2 of 23 entries
Jun 16, 2026 Study First Submitted

Notable: the plan changed

Endpoints

Primary

Objective total sleep time (TST)

Timeframe: 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 (23)

objective sleep efficiency (SE)

objective sleep latency (SL)

objective wake after sleep onset (WASO)

total time in bed (TIB)

Objective number of awakenings

Show 18 moreShow less

absolute duration of N1

proportion of N1

absolute duration of N2

Proportion of N2

absolute duration of N3 stage

Proportion of N3 stage

absolute duration of REM phase

Proportion of REM phase

Total number of sleep spindles

Density of sleep spindles

Slow wave activity

subjective sleep effectiveness

subjective sleep latency

subjective total sleep time

Subjective number of awakenings

subjective wake after sleep onset (WASO)

PSQI score

Verbal memory

Arms and interventions

Group 1Experimental

Participants of Group 1 will be using the rocking bed for the first 2 weeks after randomization.

Group 2Experimental

Participants of Group 2 will be using the rocking bed in weeks 3-4 after randomization

Devices: Somnomat - rocking bed providing vestibular stimulation during sleep

Sites

1 site in 1 country

cereneo Schweiz AG, Hertensteinstrasse 162 CH-6353Weggis, Switzerland

About this trial

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

Trial details

Enrollment: 20 participants (estimated)
Started: Feb 3, 2027
Study completion: Dec 31, 2028 (estimated)
Eligibility: 18 and older, all sexes, no healthy volunteers
Design: Interventional, randomized, open label, treatment
Conditions: Brain Injuries, Traumatic, Nerve Degeneration, Stroke, Memory Deficit Aquired Due to the Disease, e.g. Stroke, Neurodegeneration, Inflammatory Disease of CNS, Traumatic Brain Injury
First posted: Jun 18, 2026
Registry updated: Nov 3, 2026
Last verified: Jun 2026

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