The Listening Project at Reiss-Davis/Vista Del Mar Child and Family Services
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change from baseline in auditory hypersensitivity at 1 week, and at 2 months
研究概览
简要总结
A research project funded by the Reiss-Davis Child Study Center of Vista Del Mar (RDCSC/VDM) will be conducted on the Vista Del Mar campus of the RDCSC/VDM to evaluate the effectiveness of the Listening Project Protocol (LPP) in children who have difficulties with autonomic and behavior regulation in the classroom. The LPP is designed as a "neural exercise" to reduce auditory hypersensitivities, to improve auditory processing of speech, and to improve behavioral state regulation. The LPP uses acoustic stimulation to exercise the neural regulation of the middle ear structures to rehabilitate and to normalize the acoustic transfer function of the middle ear structures. The current study is being conducted to evaluate efficacy and feasibility of the LPP with emotionally disturbed and learning challenged young people and will use objective measures to evaluate changes in acoustic transfer function of the middle ears structures, auditory processing skills, physiological state regulation, sensory symptoms, and academic pre and post testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children must be between ages 6-17 years
- •children must be able to read/speak in English. Parents must be able to read/speak in either English or Spanish
- •children must be patients, students and/or residents at Reiss-Davis/Vista del Mar
排除标准
- •children who wear a hearing device
- •children with a history of heart disease
- •children who are currently being treated for a seizure disorder
- •children who are non-verbal
结局指标
主要结局
Change from baseline in auditory hypersensitivity at 1 week, and at 2 months
时间窗: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 2 months post-intervention
Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)
次要结局
- Change from baseline in auditory processing at 1 week, and at 2 months(pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 2 months post-intervention)
- Change from baseline in state regulation at 1 week, and at 2 months(pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 2 months post-intervention)
- Change from baseline in middle ear transfer function at 1 week, and at 2 months(post-intervention (within 1 week after the intervention), 2 months post-intervention)
- Change from baseline in social behavior at 1 week, and at 2 months(post-intervention (within 1 week after the intervention), 2 months post-intervention)