Vestibular Stimulation Therapy for Rhythmic Movement Disorder

F

Federal Institute of Technology (ETH) Zurich

Status

Completed

Conditions

Sleep Related Rhythmic Movement Disorder (Disorder)

Treatments

Other: Sound
Device: Somnomat B

Study type

Interventional

Funder types

Other

Identifiers

NCT03528096
RMD-SOMNOMAT

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 patients

Sex

All

Ages

5 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

6 participants in 2 patient groups

Intervention night
Experimental group
Description:
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.
Treatment:
Device: Somnomat B
Baseline night
Sham Comparator group
Description:
The sound of the moving bed is played back to the participant at the right sound intensity level.
Treatment:
Other: Sound

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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