Skip to main content
OpenTrials
Completed

NCT Number: NCT03528096

Vestibular Stimulation Therapy for 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sensory Motor Systems Lab

Zurich, Canton of Zurich, 8092, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Somnomat B

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.

Sound

Other

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

Primary outcomes

  1. Effect of Therapy on Subjective Sleep Quality

    Time frame: 2 nights

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

  2. Reliability of Automatic Detection of Symptoms

    Time frame: 3 nights

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

Secondary outcomes

  1. Effect of Therapy on Objective Sleep Quality

    Time frame: 2 nights

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

  2. Effect of Therapy on Symptoms

    Time frame: 2 nights

    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.

  3. Preferred Stimulation Parameters

    Time frame: 1.5 hours

    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).

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Collaborators

  • AIT Austrian Institute of Technology GmbH
  • University of Southampton
  • University of Zurich

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 17, 2018
Registry last updated
May 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.