Clinical trial NCT03528096: Vestibular Stimulation Therapy for Rhythmic Movement Disorder
Official title: Feasibility Study of Contactless 3D Video Assessment and 'Somnomat' Vestibular Stimulation Therapy in Childhood Rhythmic Movement Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Related Rhythmic Movement Disorder (Disorder)
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: University of Southampton
name: AIT Austrian Institute of Technology GmbH
name: University of Zurich
First posted: 2018-05-17
Enrollment: 6
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Crossover Assignment
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Effect of Therapy on Subjective Sleep Quality
timeFrame: 2 nights
measure: Reliability of Automatic Detection of Symptoms
timeFrame: 3 nights
Secondary outcomes:
measure: Effect of Therapy on Objective Sleep Quality
timeFrame: 2 nights
measure: Effect of Therapy on Symptoms
timeFrame: 2 nights
measure: Preferred Stimulation Parameters
timeFrame: 1.5 hours
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Sensory Motor Systems Lab
state: Zurich
Study officials:
affiliation: ETH Zürich
name: Robert Riener, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.