Attention Deficit Hyperactivity DisorderNCT06057441
Auditory and Visual Noise as Possible Non-pharmacological Treatment of ADHD in School Children
A study testing Auditory noise stimulation and Visual noise stimulation in people with Attention Deficit Hyperactivity Disorder and Neurodevelopmental Disorders, run by Region Skane at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder, Neurodevelopmental Disorders
- What is being tested?
- Auditory noise stimulation and Visual noise stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 1 Oct 2023to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children and adolescents with a diagnosis of ADHD and control children without a diagnosis
Who cannot join
- Intellectual disability
- Psychosis
- Severe depression or anxiety
- The need of an interpreter to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Auditory noise stimulation, Visual noise stimulation
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory noise stimulationDevice
Auditory white noise stimulation delivered at 78dB through earphones
Visual noise stimulationDevice
Visual white pixel noise stimulation, backgound pixel noise visible at computer screen
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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%. Receives: 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%. Receives: Device: Visual noise stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six months
Secondary outcomes (2)
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.
Measured: Six months
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)
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start1 Oct 2023
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Principal investigator, Emma Claesdotter-Knutsson, Region Skane
- Investigators
- Emma Claesdotter-Knutsson, MD: PhD, Principal investigator, IKVL, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057441
- Sponsor's protocol ID
- 2023-02476-01
- Other IDs
- 2023
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2023
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39146010
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auditory and Visual Noise as Possible Non-pharmacological Treatment of ADHD in School Children
- ClinicalTrials.gov ID
- NCT06057441
- Acronym / sponsor ID
- 2023-02476-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Auditory noise stimulationA prolonged fixation (PF) task and memory guided saccade (MGS) task will be performed in auditory white noise. |
| Visual white pixel noise, 25% | Active comparator | Device: Visual noise stimulationA prolonged fixation (PF) task and memory guided saccade (MGS) task will be performed in visual white pixel noise at 25%. |
| Visual white pixel noise, 50% | Active comparator | Device: Visual noise stimulationA prolonged fixation (PF) task and memory guided saccade (MGS) task will be performed in visual white pixel noise at 50%. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children and adolescents with a diagnosis of ADHD and control children without a diagnosis
Key exclusion criteria (4 listed)
- Intellectual disability
- Psychosis
- Severe depression or anxiety
- The need of an interpreter to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auditory noise stimulationAuditory white noise stimulation delivered at 78dB through earphones | Device | Auditory white noise stimulation |
| Visual noise stimulationVisual white pixel noise stimulation, backgound pixel noise visible at computer screen | Device | Visual white pixel noise, 25%, Visual white pixel noise, 50% |
Primary outcome
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.
2 secondary outcomes
SNAP
Time frame: Six months
5-15R
Time frame: Six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Derived from this study: PubMed 39146010Jostrup 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emma Claesdotter-Knutsson, MD: PhD principal investigator
IKVL, Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auditory noise stimulation and Visual noise stimulation in people with Attention Deficit Hyperactivity Disorder and Neurodevelopmental Disorders, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inhibitory control (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06057441, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.