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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Attention Deficit Hyperactivity Disorder, Neurodevelopmental Disorders

Intervention / Treatment
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* Device: Auditory noise stimulation
* Device: Visual noise stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children and adolescents with a diagnosis of ADHD and control children without a diagnosis Exclusion Criteria: Intellectual disability Psychosis Severe depression or anxiety The need of an interpreter to participate in the study

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Patients will be recruited from Child and Adolescent Psychiatry in Lund. Typically developing children (TDC) will be recruited from schools. All participants will perform a cross over control study. Participants will perform the entire test battery at one occasion, containing no noise, auditory white noise and visual white pixel noise (two levels). Participants in the ADHD group will perform the tests unmedicated. The order of the noise stimulation and no noise, as well as the order of the tasks, will be randomized over participants.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No noise stimulation<br>A prolonged fixation (PF) task and memory guided saccade (MGS) task will be performed without noise. | |
| Active Comparator: Auditory white noise stimulation<br>A prolonged fixation (PF) task and memory guided saccade (MGS) task will be performed in auditory white noise. | Device: Auditory noise stimulation<br>* Auditory white noise stimulation delivered at 78dB through earphones<br>|
| Active Comparator: Visual white pixel noise, 25%<br>A prolonged fixation (PF) task and memory guided saccade (MGS) task will be performed in visual white pixel noise at 25%. | Device: Visual noise stimulation<br>* Visual white pixel noise stimulation, backgound pixel noise visible at computer screen<br>|
| Active Comparator: Visual white pixel noise, 50%<br>A prolonged fixation (PF) task and memory guided saccade (MGS) task will be performed in visual white pixel noise at 50%. | Device: Visual noise stimulation<br>* Visual white pixel noise stimulation, backgound pixel noise visible at computer screen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inhibitory control | 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. | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SNAP | The SNAP rating scale is an assessment tool for traits of hyperactivity and inattention in ADHD (Swanson et al., 2012). Will be filled out by legal guardians of the participants. | Six months | 
| 5-15R | The 5-15R assessment is aimed at legal guardians of the participants and consists of 181 claims that evaluates motor and cognitive performance in children aged 5 to 15 as well as a psychiatric assessment (Kadesjö et al., 2017) | Six months |