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Vestibular Stimulation Therapy for Rhythmic Movement Disorder

Primary Purpose

Sleep Related Rhythmic Movement Disorder (Disorder)

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Somnomat B
Sound
Sponsored by
Swiss Federal Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Related Rhythmic Movement Disorder (Disorder)

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Sensory Motor Systems Lab

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Intervention night

Baseline night

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Effect of Therapy on Objective Sleep Quality
Sleep quality is determined based on 2D video recordings and compared between baseline and intervention nights.
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.
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).

Full Information

First Posted
May 4, 2018
Last Updated
May 16, 2018
Sponsor
Swiss Federal Institute of Technology
Collaborators
University of Southampton, AIT Austrian Institute of Technology GmbH, University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT03528096
Brief Title
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

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
March 30, 2018 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Federal Institute of Technology
Collaborators
University of Southampton, AIT Austrian Institute of Technology GmbH, University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Related Rhythmic Movement Disorder (Disorder)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Crossover Assignment
Masking
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.
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention night
Arm Type
Experimental
Arm Description
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.
Arm Title
Baseline night
Arm Type
Sham Comparator
Arm Description
The sound of the moving bed is played back to the participant at the right sound intensity level.
Intervention Type
Device
Intervention Name(s)
Somnomat B
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sound
Intervention Description
Sound of the moving bed was recorded and played back during the baseline night.
Primary Outcome Measure Information:
Title
Effect of Therapy on Subjective Sleep Quality
Description
Difference in perceived sleep quality between baseline and intervention nights. Data is collected in the first hour after awakening using a questionnaire.
Time Frame
2 nights
Title
Reliability of Automatic Detection of Symptoms
Description
Episodes of rhythmic movement scored by an algorithm using 3D Video will be compared to the scoring of an expert
Time Frame
3 nights
Secondary Outcome Measure Information:
Title
Effect of Therapy on Objective Sleep Quality
Description
Sleep quality is determined based on 2D video recordings and compared between baseline and intervention nights.
Time Frame
2 nights
Title
Effect of Therapy on Symptoms
Description
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.
Time Frame
2 nights
Title
Preferred Stimulation Parameters
Description
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).
Time Frame
1.5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Riener, Prof. Dr.
Organizational Affiliation
ETH Zürich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sensory Motor Systems Lab
City
Zürich
State/Province
Zurich
ZIP/Postal Code
8092
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31681030
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.
Results Reference
derived

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Vestibular Stimulation Therapy for Rhythmic Movement Disorder

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