Feasibility Study of Contactless 3D Video Assessment and 'Somnomat' Vestibular Stimulation Therapy in Childhood Rhythmic Movement Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Effect of Therapy on Subjective Sleep Quality
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Effect of Therapy on Subjective Sleep Quality
时间窗: 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
时间窗: 3 nights
Episodes of rhythmic movement scored by an algorithm using 3D Video will be compared to the scoring of an expert
次要结局
- Effect of Therapy on Symptoms(2 nights)
- Effect of Therapy on Objective Sleep Quality(2 nights)
- Preferred Stimulation Parameters(1.5 hours)