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

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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Neurodevelopmental Disorders Device: Auditory noise stimulation Device: Visual noise stimulation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Official Title: Auditory and Visual Noise as Possible Non-pharmacological Treatment of ADHD in School Children
Actual Study Start Date : October 1, 2023
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Noise

Arms and Interventions
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Arm Intervention/treatment
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.
 Device: Auditory noise stimulation
Auditory white noise stimulation delivered at 78dB through earphones
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%.
 Device: Visual noise stimulation
Visual white pixel noise stimulation, backgound pixel noise visible at computer screen
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%.
 Device: Visual noise stimulation
Visual white pixel noise stimulation, backgound pixel noise visible at computer screen


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06057441


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

Locations
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Sweden
Child and Adolescent Psychiatry Clinic Recruiting
Lund, Sweden
Contact: Emma Claesdotter-Knutsson, MD; PhD    0046768871765    emma.claesdotter-knutsson@med.lu.se   
Sponsors and Collaborators
Region Skane
Lund University
Investigators
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Principal Investigator: Emma Claesdotter-Knutsson, MD: PhD IKVL, Lund University
More Information
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Responsible Party: Emma Claesdotter-Knutsson, Associate Professor, Region Skane
ClinicalTrials.gov Identifier: NCT06057441    
Other Study ID Numbers: 2023-02476-01
First Posted: September 28, 2023    Key Record Dates
Last Update Posted: March 1, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Neurodevelopmental Disorders
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders