An interventional study of Somnomat B and Sound in Sleep Related Rhythmic Movement Disorder (Disorder), sponsored by Swiss Federal Institute of Technology. Completed at 1 site in Switzerland. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2018-05-17.
Sponsored by Swiss Federal Institute of Technology · Not applicable, Interventional, and Treatment
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.
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.
320 studies on the registry are indexed under Movement Disorders; 98 are open to participants now.
This study's enrollment of 6 is below the median of 46 across 180 interventional studies indexed under Movement Disorders.
Browse Movement Disorders studies →Swiss Federal Institute of Technology is the lead sponsor of 152 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
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
The sound of the moving bed is played back to the participant at the right sound intensity level.
Other: Sound
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.
Sound of the moving bed was recorded and played back during the baseline night.
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.
Time frame: 2 nights
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
Time frame: 3 nights
Effect of Therapy on Objective Sleep Quality
Sleep quality is determined based on 2D video recordings and compared between baseline and intervention nights.
Time frame: 2 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.
Time frame: 2 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).
Time frame: 1.5 hours
Plan to share: No
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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Swiss Federal Institute of Technology