Vestibular Stimulation Therapy for Rhythmic Movement Disorder

Sleep Related Rhythmic Movement Disorder (Disorder) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03528096
• Other study ID #: RMD-SOMNOMAT
• Status: Completed
• Phase: N/A
• Start date: March 30, 2018
• Est. completion date: April 30, 2018

Study information

• Verified date: May 2018
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: April 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Movement Disorders
• Sleep Related Rhythmic Movement Disorder (Disorder)

Intervention

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.

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

Locations

Country	Name	City	State
Switzerland	Sensory Motor Systems Lab	Zürich	Zurich

Sponsors (4)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	AIT Austrian Institute of Technology GmbH, University of Southampton, University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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