Vestibular Stimulation Therapy for Rhythmic Movement Disorder

Swiss Federal Institute of Technology6 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Interventions

Somnomat BDEVICE

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.

SoundOTHER

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

Eligibility

Sex: ALLMin age: 5 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Sensory Motor Systems Lab

Zurich, Canton of Zurich, Switzerland

Outcomes

Primary Outcomes

Effect of Therapy on Subjective Sleep Quality

Difference in perceived sleep quality between baseline and intervention nights. Data is collected in the first hour after awakening using a questionnaire.

Time frame: 2 nights

Reliability of Automatic Detection of Symptoms

Episodes of rhythmic movement scored by an algorithm using 3D Video will be compared to the scoring of an expert

Time frame: 3 nights

Secondary Outcomes

Effect of Therapy on Objective Sleep Quality

Sleep quality is determined based on 2D video recordings and compared between baseline and intervention nights.

Time frame: 2 nights

Effect of Therapy on Symptoms

Severity of symptoms is determined based on 2D video recordings. The number of episodes of rhytmic movement (count) and the duration of episodes (minutes) compared between baseline and intervention nights.

Time frame: 2 nights

Preferred Stimulation Parameters

Participants can try out different directions of movement (pitch or roll) and different movement frequencies between 0 and 2 Hz and choose their preferred settings (one direction + one frequency).

Time frame: 1.5 hours

Data from ClinicalTrials.gov

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