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
|Condition or disease||Intervention/treatment||Phase|
|Sleep Related Rhythmic Movement Disorder (Disorder)||Device: Somnomat B Other: Sound||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Crossover Assignment|
|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.|
|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|
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.
Sound of the moving bed was recorded and played back during the baseline night.
- 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.
- 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
- 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.
- 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.
- 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).
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
|Sensory Motor Systems Lab|
|Zürich, Zurich, Switzerland, 8092|
|Principal Investigator:||Robert Riener, Prof. Dr.||ETH Zürich|