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

Primary Purpose

Attention Deficit Hyperactivity Disorder, Neurodevelopmental Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Auditory noise stimulation
Visual noise stimulation
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder

Eligibility Criteria

8 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Child and Adolescent Psychiatry Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

Active Comparator

Active Comparator

Arm Label

No noise stimulation

Auditory white noise stimulation

Visual white pixel noise, 25%

Visual white pixel noise, 50%

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

SNAP
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
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)

Full Information

First Posted
September 12, 2023
Last Updated
September 21, 2023
Sponsor
Region Skane
Collaborators
Lund University
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1. Study Identification

Unique Protocol Identification Number
NCT06057441
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Skane
Collaborators
Lund University

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder, Neurodevelopmental Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No noise stimulation
Arm Type
No Intervention
Arm Description
A prolonged fixation (PF) task and memory guided saccade (MGS) task will be performed without noise.
Arm Title
Auditory white noise stimulation
Arm Type
Active Comparator
Arm Description
A prolonged fixation (PF) task and memory guided saccade (MGS) task will be performed in auditory white noise.
Arm Title
Visual white pixel noise, 25%
Arm Type
Active Comparator
Arm Description
A prolonged fixation (PF) task and memory guided saccade (MGS) task will be performed in visual white pixel noise at 25%.
Arm Title
Visual white pixel noise, 50%
Arm Type
Active Comparator
Arm Description
A prolonged fixation (PF) task and memory guided saccade (MGS) task will be performed in visual white pixel noise at 50%.
Intervention Type
Device
Intervention Name(s)
Auditory noise stimulation
Intervention Description
Auditory white noise stimulation delivered at 78dB through earphones
Intervention Type
Device
Intervention Name(s)
Visual noise stimulation
Intervention Description
Visual white pixel noise stimulation, backgound pixel noise visible at computer screen
Primary Outcome Measure Information:
Title
Inhibitory control
Description
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.
Time Frame
Six months
Secondary Outcome Measure Information:
Title
SNAP
Description
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.
Time Frame
Six months
Title
5-15R
Description
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)
Time Frame
Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emma Claesdotter-Knutsson, MD: PhD
Phone
0046768871765
Email
emma.claesdotter-knutsson@skane.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emma Claesdotter-Knutsson, MD: PhD
Organizational Affiliation
IKVL, Lund University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Child and Adolescent Psychiatry Clinic
City
Lund
Country
Sweden
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Claesdotter-Knutsson, MD; PhD
Phone
0046768871765
Email
emma.claesdotter-knutsson@med.lu.se

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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