Vestibular Stimulation Therapy for Rhythmic Movement Disorder

Feasibility Study of Contactless 3D Video Assessment and 'Somnomat' Vestibular Stimulation Therapy in Childhood Rhythmic Movement Disorder

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 Overview

• Status: Completed
• Conditions: Sleep Related Rhythmic Movement Disorder (Disorder)
• Intervention / Treatment: Device: Somnomat B; Other: Sound

Detailed Description

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
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich
    • Zürich, Zurich, Switzerland, 8092
      • Sensory Motor Systems Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 16 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
Sham Comparator: Baseline night; The sound of the moving bed is played back to the participant at the right sound intensity level.	Other: Sound; Sound of the moving bed was recorded and played back during the baseline night.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	3 nights

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of Therapy on Objective Sleep Quality	Sleep quality is determined based on 2D video recordings and compared between baseline and intervention nights.	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.	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).	1.5 hours

Collaborators and Investigators

• Sponsor: Swiss Federal Institute of Technology
• Collaborators: University of Zurich; University of Southampton; AIT Austrian Institute of Technology GmbH
• Investigators: Principal Investigator: Robert Riener, Prof. Dr., ETH Zurich

Publications and helpful links

General Publications

• Gall M, Kohn B, Wiesmeyr C, van Sluijs RM, Wilhelm E, Rondei Q, Jager L, Achermann P, Landolt HP, Jenni OG, Riener R, Garn H, Hill CM. A Novel Approach to Assess Sleep-Related Rhythmic Movement Disorder in Children Using Automatic 3D Analysis. Front Psychiatry. 2019 Oct 16;10:709. doi: 10.3389/fpsyt.2019.00709. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2018
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): April 30, 2018

Study Registration Dates

• First Submitted: May 4, 2018
• First Submitted That Met QC Criteria: May 16, 2018
• First Posted (Actual): May 17, 2018

Study Record Updates

• Last Update Posted (Actual): May 17, 2018
• Last Update Submitted That Met QC Criteria: May 16, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Disease; Movement Disorders
• Other Study ID Numbers: RMD-SOMNOMAT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No