Vestibular Stimulation Therapy for Rhythmic Movement Disorder

Sponsor

Swiss Federal Institute of Technology (Other)

Overall Status

Completed

CT.gov ID

NCT03528096

Collaborator

University of Southampton (Other), AIT Austrian Institute of Technology GmbH (Other), University of Zurich (Other)

Enrollment

Location

Arms

Actual Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Related Rhythmic Movement Disorder (Disorder)	Device: Somnomat B Other: Sound	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Crossover AssignmentCrossover Assignment

Masking:

Single (Participant)

Masking Description:

Blinding of the participants is impossible, as the stimulation is easy to perceive and cannot be confused with a baseline night. Therefore, participants are informed about the character of the night (max. 5 minutes) before the moment of lights off. For safety reasons the experimenter that is present is also aware of the condition.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 30, 2018

Actual Primary Completion Date :

Apr 30, 2018

Actual Study Completion Date :

Apr 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention night 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.	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.
Sham Comparator: Baseline night The sound of the moving bed is played back to the participant at the right sound intensity level.	Other: Sound Sound of the moving bed was recorded and played back during the baseline night.

Arm

Intervention/Treatment

Experimental: Intervention night

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.

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.

Sham Comparator: Baseline night

The sound of the moving bed is played back to the participant at the right sound intensity level.

Other: Sound

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

Outcome Measures

Primary Outcome Measures

Effect of Therapy on Subjective Sleep Quality [2 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 Symptoms [3 nights]
Episodes of rhythmic movement scored by an algorithm using 3D Video will be compared to the scoring of an expert

Secondary Outcome Measures

Effect of Therapy on Objective Sleep Quality [2 nights]
Sleep quality is determined based on 2D video recordings and compared between baseline and intervention nights.
Effect of Therapy on Symptoms [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.
Preferred Stimulation Parameters [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sensory Motor Systems Lab	Zürich	Zurich	Switzerland	8092

Sponsors and Collaborators

Swiss Federal Institute of Technology
University of Southampton
AIT Austrian Institute of Technology GmbH
University of Zurich

Investigators

Principal Investigator: Robert Riener, Prof. Dr., ETH Zürich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Swiss Federal Institute of Technology

ClinicalTrials.gov Identifier:

NCT03528096

Other Study ID Numbers:

RMD-SOMNOMAT

First Posted:

May 17, 2018

Last Update Posted:

May 17, 2018

Last Verified:

May 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Movement Disorders

Disease

Study Results

No Results Posted as of May 17, 2018