NCT03528096

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 17, 2018

Completed
Last Updated

May 17, 2018

Status Verified

May 1, 2018

Enrollment Period

1 month

First QC Date

May 4, 2018

Last Update Submit

May 16, 2018

Conditions

Sleep Related Rhythmic Movement Disorder (Disorder)

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    3 nights

Secondary Outcomes (3)

  • Effect of Therapy on Objective Sleep Quality

    2 nights

  • Effect of Therapy on Symptoms

    2 nights

  • Preferred Stimulation Parameters

    1.5 hours

Study Arms (2)

Intervention night

EXPERIMENTAL

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

Baseline night

SHAM COMPARATOR

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

Other: Sound

Interventions

Somnomat BDEVICE

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 night
SoundOTHER

Sound of the moving bed was recorded and played back during the baseline night.

Baseline night

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sensory Motor Systems Lab

Zurich, Canton of Zurich, 8092, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 31681030DERIVED

MeSH Terms

Interventions

Sound

Intervention Hierarchy (Ancestors)

Radiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Robert Riener, Prof. Dr.

    ETH Zürich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Crossover Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2018

First Posted

May 17, 2018

Study Start

March 30, 2018

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

May 17, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)