Clinical trial NCT06057441: Auditory and Visual Noise as Possible Non-pharmacological Treatment of ADHD in School Children
Official title: Auditory and Visual Noise as Possible Non-pharmacological Treatment of ADHD in School Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Neurodevelopmental Disorders
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Lund University
First posted: 2023-09-28
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Inhibitory control
timeFrame: Six months
Secondary outcomes:
measure: SNAP
timeFrame: Six months
measure: 5-15R
timeFrame: Six months
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Child and Adolescent Psychiatry Clinic
Study officials:
affiliation: IKVL, Lund University
name: Emma Claesdotter-Knutsson, MD: PhD
role: PRINCIPAL_INVESTIGATOR
References: