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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06057441
• Other study ID #: 2023-02476-01
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: June 2025

Study information

• Verified date: February 2024
• Source: Region Skane
• Contact: Emma Claesdotter-Knutsson, MD: PhD
• Phone: 0046768871765
• Email: emma.claesdotter-knutsson[@]skane.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Neurodevelopmental Disorders

Intervention

Device:
• Auditory noise stimulation
Auditory white noise stimulation delivered at 78dB through earphones
• Visual noise stimulation
Visual white pixel noise stimulation, backgound pixel noise visible at computer screen

Locations

Country	Name	City	State
Sweden	Child and Adolescent Psychiatry Clinic	Lund

Sponsors (2)

Lead Sponsor	Collaborator
Region Skane	Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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