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Vestibular Stimulation Therapy for Rhythmic Movement Disorder

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

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.


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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

Resource links provided by the National Library of Medicine


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.




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).



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03528096


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Movement Disorders
Disease
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases