Vestibular Stimulation Therapy for Rhythmic Movement Disorder

• ClinicalTrials.gov Identifier: NCT03528096
• Recruitment Status: Completed
• First Posted: May 17, 2018
• Last Update Posted: May 17, 2018
• Sponsor: Swiss Federal Institute of Technology
• Collaborators: University of Southampton; AIT Austrian Institute of Technology GmbH; University of Zurich
• Information provided by (Responsible Party): Swiss Federal Institute of Technology

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	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 6 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: Crossover 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: March 30, 2018
• Actual Primary Completion Date: April 30, 2018
• Actual Study Completion Date: April 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.

Outcome Measures

Primary Outcome Measures :

1. Effect of Therapy on Subjective Sleep Quality [ Time Frame: 2 nights ]
   Difference in perceived sleep quality between baseline and intervention nights. Data is collected in the first hour after awakening using a questionnaire.
2. Reliability of Automatic Detection of Symptoms [ Time Frame: 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 :

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

• Ages Eligible for Study: 5 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Switzerland

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gall M, Kohn B, Wiesmeyr C, van Sluijs RM, Wilhelm E, Rondei Q, Jäger 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.

• Responsible Party: Swiss Federal Institute of Technology
• ClinicalTrials.gov Identifier: NCT03528096 History of Changes
• Other Study ID Numbers: RMD-SOMNOMAT
• First Posted: May 17, 2018
• Last Update Posted: May 17, 2018
• Last Verified: May 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Movement Disorders; Disease; Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases