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

• ClinicalTrials.gov Identifier: NCT06057441
• Recruitment Status: Recruiting
• First Posted: September 28, 2023
• Last Update Posted: March 1, 2024
• Sponsor: Region Skane
• Collaborator: Lund University
• Information provided by (Responsible Party): Emma Claesdotter-Knutsson, Region Skane

Tracking Information

• First Submitted Date: September 12, 2023
• First Posted Date: September 28, 2023
• Last Update Posted Date: March 1, 2024
• Actual Study Start Date: October 1, 2023
• Estimated Primary Completion Date: June 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 21, 2023)

Inhibitory control [ Time Frame: Six months ]

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 21, 2023)

• SNAP [ Time Frame: Six months ]
  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.
• 5-15R [ Time Frame: Six months ]
  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)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Crossover Assignment
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.

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

• Attention Deficit Hyperactivity Disorder
• Neurodevelopmental Disorders

Intervention

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

Study Arms

• No Intervention: No noise stimulation
  A prolonged fixation (PF) task and memory guided saccade (MGS) task will be performed without noise.
• Active Comparator: Auditory white noise stimulation
  A prolonged fixation (PF) task and memory guided saccade (MGS) task will be performed in auditory white noise.
  Intervention: Device: Auditory noise stimulation
• Active Comparator: 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%.
  Intervention: Device: Visual noise stimulation
• Active Comparator: 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%.
  Intervention: Device: Visual noise stimulation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 21, 2023): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2025
• Estimated Primary Completion Date: June 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 8 Years to 17 Years (Child)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Emma Claesdotter-Knutsson, MD: PhD; 0046768871765; emma.claesdotter-knutsson@skane.se

• Listed Location Countries: Sweden

Administrative Information

• NCT Number: NCT06057441
• Other Study ID Numbers: 2023-02476-01
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Emma Claesdotter-Knutsson, Region Skane
• Original Responsible Party: Same as current
• Current Study Sponsor: Region Skane
• Original Study Sponsor: Same as current
• Collaborators: Lund University

Investigators

• Principal Investigator: Emma Claesdotter-Knutsson, MD: PhD; IKVL, Lund University

• PRS Account: Region Skane
• Verification Date: February 2024