- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06057441
Auditory and Visual Noise as Possible Non-pharmacological Treatment of ADHD in School Children
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.
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lund, Sweden
- Child and Adolescent Psychiatry Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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%.
|
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%.
|
Visual white pixel noise stimulation, backgound pixel noise visible at computer screen
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Six months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Six months
|
|
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)
|
Six months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Emma Claesdotter-Knutsson, MD: PhD, IKVL, Lund University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-02476-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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