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Vestibular Stimulation Therapy for Rhythmic Movement Disorder

Not Applicable
Completed
Conditions
Sleep Related Rhythmic Movement Disorder (Disorder)
Interventions
Other: Sound
Device: Somnomat B
Registration Number
NCT03528096
Lead Sponsor
Swiss Federal Institute of Technology
Brief Summary

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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
6
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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Baseline nightSoundThe sound of the moving bed is played back to the participant at the right sound intensity level.
Intervention nightSomnomat BVestibular 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.
Primary Outcome Measures
NameTimeMethod
Effect of Therapy on Subjective Sleep Quality2 nights

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

Reliability of Automatic Detection of Symptoms3 nights

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

Secondary Outcome Measures
NameTimeMethod
Effect of Therapy on Symptoms2 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.

Effect of Therapy on Objective Sleep Quality2 nights

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

Preferred Stimulation Parameters1.5 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).

Trial Locations

Locations (1)

Sensory Motor Systems Lab

🇨🇭

Zürich, Zurich, Switzerland

Sensory Motor Systems Lab
🇨🇭Zürich, Zurich, Switzerland
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