Vestibular Stimulation Therapy for Rhythmic Movement Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-30

Study Completion Date

2018-04-30

Brief Summary

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This study aims to a) investigate the feasibility of the detection of episodes of RMD using contactless 3D video analysis and customised analysis software and b) the use of vestibular stimulation as a therapy for childhood rhythmic movement disorder.

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Detailed Description

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Rhythmic movement disorder (RMD) is a childhood onset sleep disorder that is characterised by repetitive movements that involve large muscle groups, such as body rocking, rolling and head banging. These rhythmic movements are performed prior to and during sleep and as such can disturb sleep with clinical consequences. There is no standard measure to quantify the severity of rhythmic movements. 3D video offers a contactless method of achieving this without disrupting the child's sleep. Vestibular stimulation has a soothing effect and might be effective in promoting sleep. Furthermore, mild vestibular stimulation in the form of gentle rocking movements generated by the Somnomat device might function as a stimulation substitute for the child's RMD with therapeutic potential.

This study aims to a) investigate the feasibility of the detection of episodes of RMD using contactless 3D video analysis and customised analysis software and b) the use of vestibular stimulation as a therapy for childhood rhythmic movement disorder.

Conditions

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Sleep Related Rhythmic Movement Disorder (Disorder)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Crossover Assignment

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Blinding of the participants is impossible, as the stimulation is easy to perceive and cannot be confused with a baseline night. Therefore, participants are informed about the character of the night (max. 5 minutes) before the moment of lights off. For safety reasons the experimenter that is present is also aware of the condition.

Study Groups

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Intervention night

Vestibular stimulation, in the form of gentle rocking movements, is provided using the Somnomat B rocking bed. Stimulation is provided for the first 60 minutes of the night and for 10 minutes upon detection of symptoms. The stimulation frequency is in the range of 0.25-2 Hz.

Group Type EXPERIMENTAL

Somnomat B

Intervention Type DEVICE

Vestibular stimulation is provided using an innervated bed platform. This robotic device consists of a standard single bed, mounted on a moving mechanism. It was developed and produced by the ETH Zürich and approved for use in this study by Swissmedic.

Baseline night

The sound of the moving bed is played back to the participant at the right sound intensity level.

Group Type SHAM_COMPARATOR

Sound

Intervention Type OTHER

Sound of the moving bed was recorded and played back during the baseline night.

Interventions

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Somnomat B

Vestibular stimulation is provided using an innervated bed platform. This robotic device consists of a standard single bed, mounted on a moving mechanism. It was developed and produced by the ETH Zürich and approved for use in this study by Swissmedic.

Intervention Type DEVICE

Sound

Sound of the moving bed was recorded and played back during the baseline night.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* RMD diagnosis based on ICSD III criteria or RMD suspected
* Typically developing
* Child and accompanying adult are legally allowed to enter Switzerland without a visa
* Both child and parent/legal guardian understand easy English or German

Exclusion Criteria

* Moderate or severe learning disability
* Neurological disorder (incl. autism, epilepsy, medicinally treated ADHD)
* Currently using medication that influences sleep
* Known diseases of the vestibular system
* Self-reported sensitivity for motion sickness
* Body height \> 1.95 m (due to the constraints of the setup)
* Body weight \> 130 kg (due to the constraints of the setup)
* Flu, cold or other acute disease on study day that might influence measurements
* Pregnancy

Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No