Sleep Related Rhythmic Movement Disorder (Disorder)NCT03528096
Vestibular Stimulation Therapy for Rhythmic Movement Disorder
A study testing Somnomat B and Sound in people with Sleep Related Rhythmic Movement Disorder (Disorder), run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Sleep Related Rhythmic Movement Disorder (Disorder)
- What is being tested?
- Somnomat B and Sound
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Mar 2018to 30 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Sensory Motor Systems Lab
Zurich, Canton of Zurich, 8092
About this study
Official title: Feasibility Study of Contactless 3D Video Assessment and 'Somnomat' Vestibular Stimulation Therapy in Childhood Rhythmic Movement Disorder
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.
Read the 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.
- Being tested
- Somnomat B, Sound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
SoundOther
Sound of the moving bed was recorded and played back during the baseline night.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 3 nights
Secondary outcomes (3)
Effect of Therapy on Objective Sleep Quality
Sleep quality is determined based on 2D video recordings and compared between baseline and intervention nights.
Measured: 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.
Measured: 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).
Measured: 1.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start30 Mar 2018
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Related Rhythmic Movement Disorder (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Crossover Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southampton, AIT Austrian Institute of Technology GmbH, University of Zurich
- Responsible party
- Sponsor
- Investigators
- Robert Riener, Prof. Dr., Principal investigator, ETH Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528096
- Sponsor's protocol ID
- RMD-SOMNOMAT
- Status last verified
- May 2018
- First submitted
- 4 May 2018
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31681030
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Contactless 3D Video Assessment and 'Somnomat' Vestibular Stimulation Therapy in Childhood Rhythmic Movement Disorder
- ClinicalTrials.gov ID
- NCT03528096
- Acronym / sponsor ID
- RMD-SOMNOMAT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- University of Southampton, AIT Austrian Institute of Technology GmbH, University of Zurich
- Study start
- 30 Mar 2018 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 17 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Crossover Assignment
| Arm | Type | Receives |
|---|---|---|
| Intervention night | Experimental | Device: Somnomat BVestibular 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. |
| Baseline night | Sham comparator | Other: SoundThe sound of the moving bed is played back to the participant at the right sound intensity level. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Somnomat BVestibular 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. | Device | Intervention night |
| SoundSound of the moving bed was recorded and played back during the baseline night. | Other | Baseline night |
Primary outcome
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
3 secondary outcomes
Effect of Therapy on Objective Sleep Quality
Time frame: 2 nights
Effect of Therapy on Symptoms
Time frame: 2 nights
Preferred Stimulation Parameters
Time frame: 1.5 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
- Derived from this study: PubMed 31681030Gall 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Riener, Prof. Dr. principal investigator
ETH Zürich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Somnomat B and Sound in people with Sleep Related Rhythmic Movement Disorder (Disorder), run by Swiss Federal Institute of Technology at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Therapy on Subjective Sleep Quality (time frame: 2 nights). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03528096, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2018.