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

NCT06057441 | Completed

• 1 other identifier: 2023-02476-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder; Neurodevelopmental Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• SNAP

  Six months

• 5-15R

  Six months

Study Arms (4)

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.

Device: Auditory noise stimulation

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%.

Device: Visual noise stimulation

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%.

Device: Visual noise stimulation

Interventions

Auditory noise stimulation DEVICE

Auditory white noise stimulation delivered at 78dB through earphones

Auditory white noise stimulation

Visual noise stimulation DEVICE

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

Visual white pixel noise, 25%; Visual white pixel noise, 50%

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Region Skane: lead
• Lund University: collaborator

Study Sites (1)

Child and Adolescent Psychiatry Clinic

Lund, Sweden

Location

Related Publications (1)

• 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.

  PMID: 39146010 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Mental Disorders

Study Officials

• Emma Claesdotter-Knutsson, MD: PhD

  IKVL, Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 28, 2023
• Study Start: October 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)