跳至主要内容
临床试验/NCT06057441
NCT06057441已完成不适用

Auditory and Visual Noise as Possible Non-pharmacological Treatment of ADHD in School Children

Region Skane1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Region Skane
入组人数
60
试验地点
1
主要终点
Inhibitory control

研究概览

简要总结

The goal of this study is to compare the influence of visual and auditory white noise on performance in children with attention deficit hyperactivity disorder (ADHD). The main questions it aims to answer are:

  • Can auditory white noise stimulation affect cognitive performance?
  • Can visual white pixel noise affect cognitive performance? Participants will complete two eye tracking tasks under different sensory noise stimulation.

Researchers will compare the ADHD group with a group of typically developing children to see if the noise influences the groups differently and if it has the potential to affect the performance of the ADHD group, to reach the level of the control group.

详细描述

Attention Deficit Hyperactivity disorder (ADHD) is one of the most frequent childhood disorders with an estimated prevalence of about 5%. Multimodal treatment is recommended in both national and international guidelines of ADHD care, but most patients only receive pharmacological treatment, sometimes in combination with parent training. As such, the most common treatment approach today is stimulant medication, e.g., methylphenidate. However, there are insufficient understanding about several aspects of medical treatment. For example, it is not evident that medication improves learning processes and the best dosage for cognitive functioning and adapted school behavior differs.

Original findings from our research group shows that auditory noise has the possibility of enhancing cognitive performance in inattentive children without diagnosis as well as children with an ADHD diagnosis. One study found that the benefit of noise was in parity with, or even larger than, the benefit of pharmacological ADHD treatment on two cognitive tasks. The theory about noise benefit is thoroughly described by Sikström and Söderlund (2007). If auditory or visual noise, as suggested by the present project, could be a complement, or an alternative, to stimulant medication it could fundamentally change the treatment of ADHD and the school situation for those children.

The aims of this study are to: i) evaluate the effects of auditory white noise and visual white pixel noise on cognitive performance during two eye tracking tasks, ii) compare effects between ADHD and control groups ii) link noise benefit to specific traits.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
8 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children and adolescents with a diagnosis of ADHD and control children without a diagnosis

排除标准

  • Intellectual disability
  • Psychosis
  • Severe depression or anxiety
  • The need of an interpreter to participate in the study

研究组 & 干预措施

No noise stimulation

No Intervention

A prolonged fixation (PF) task and memory guided saccade (MGS) task will be performed without noise.

Auditory white noise stimulation

Active Comparator

A prolonged fixation (PF) task and memory guided saccade (MGS) task will be performed in auditory white noise.

干预措施: Auditory noise stimulation (Device)

Visual white pixel noise, 25%

Active Comparator

A prolonged fixation (PF) task and memory guided saccade (MGS) task will be performed in visual white pixel noise at 25%.

干预措施: Visual noise stimulation (Device)

Visual white pixel noise, 50%

Active Comparator

A prolonged fixation (PF) task and memory guided saccade (MGS) task will be performed in visual white pixel noise at 50%.

干预措施: Visual noise stimulation (Device)

结局指标

主要结局

Inhibitory control

时间窗: Six months

Inhibitory control is the ability to suppress nonproductive behaviors and cognitive processing and will be measured through the eye tracking tasks (PF and MGS) in the study.

次要结局

  • SNAP(Six months)
  • 5-15R(Six months)

研究者

发起方
Region Skane
申办方类型
Other
责任方
Principal Investigator
主要研究者

Emma Claesdotter-Knutsson

Associate Professor

Region Skane

研究点 (1)

Loading locations...

相似试验