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

NCT ID: NCT06057441

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-06-01

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.

Conditions

Attention Deficit Hyperactivity Disorder; Neurodevelopmental Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

No noise stimulation

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Auditory white noise stimulation

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

Group Type: ACTIVE_COMPARATOR

Auditory noise stimulation

Intervention Type: DEVICE

Auditory white noise stimulation delivered at 78dB through earphones

Visual white pixel noise, 25%

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

Group Type: ACTIVE_COMPARATOR

Visual noise stimulation

Intervention Type: DEVICE

Visual white pixel noise stimulation, backgound pixel noise visible at computer screen

Visual white pixel noise, 50%

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

Group Type: ACTIVE_COMPARATOR

Visual noise stimulation

Intervention Type: DEVICE

Visual white pixel noise stimulation, backgound pixel noise visible at computer screen

Interventions

Auditory noise stimulation

Auditory white noise stimulation delivered at 78dB through earphones

Intervention Type: DEVICE

Visual noise stimulation

Visual white pixel noise stimulation, backgound pixel noise visible at computer screen

Intervention Type: DEVICE

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lund University

OTHER

Sponsor Role: collaborator

Region Skane

OTHER

Sponsor Role: lead

Responsible Party

Emma Claesdotter-Knutsson

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emma Claesdotter-Knutsson, MD: PhD

Role: PRINCIPAL_INVESTIGATOR

IKVL, Lund University

Locations

Child and Adolescent Psychiatry Clinic

Lund, , Sweden

Countries

Sweden

References

Jostrup E, Nystrom M, Tallberg P, Soderlund G, Gustafsson P, Claesdotter-Knutsson E. Effects of Auditory and Visual White Noise on Oculomotor Inhibition in Children With Attention-Deficit/Hyperactivity Disorder: Protocol for a Crossover Study. JMIR Res Protoc. 2024 Aug 15;13:e56388. doi: 10.2196/56388.

Reference Type: DERIVED

PMID: 39146010 (View on PubMed)

Other Identifiers

2023-02476-01

Identifier Type: -

Identifier Source: org_study_id