Attention Deficit Hyperactivity DisorderNCT06234033
Neural Mechanisms of Sensory Processing Anomalies
An observational study of Attention Deficit Hyperactivity Disorder and Autism Spectrum Disorder, run by Aalborg University at 1 site in Denmark.
Trial summary
To assess sensory processing anomalies in neurotypical children, children with autism spectrum disorder, and attention-deficit hyperactivity disorder, particularly within the vibrotactile and auditory sensory modalities. Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder, Autism Spectrum Disorder, Sensory Processing Disorder
- What is being tested?
- Discrimination Acuity test, Transiently Evoked Otoacoustic Emission and Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 75 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2023to 31 Oct 2025
- Phase
- Observational
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Study population: The study population include three well-defined groups of subjects: 1. Children with a diagnosis of ASD from the local Child and Adolescent Psychiatry clinic. 2. Children with a diagnosis of ADHD from the local Child and Adolescent Psychiatry clinic. 3. Neurotypical children without any psychiatric or neurologic diagnosis.
Who may be able to join
- Clinically diagnosed with either ADHD, ASD, or no diagnosis (typical development)
- Between 8-15 years old
Who cannot join
- Familiar history of schizophrenia and depression.
- Epilepsy, cerebral palsy, traumatic brain injury
- Musculoskeletal illnesses
- Hearing or visual impairment that cannot be corrected
- Lack of ability to cooperate
- Parents cannot read Danish
Trial locations and contacts
1 site in 1 country.
Daniel Skak Mazhari-Jensen contact
Denmark1 site, 1 recruiting
- Recruiting
Health Science and Technology
Aalborg, North Denmark, 9260
Sabata Gervasio, 9940 8820, saba@hst.aau.dk
Daniel Skak Mazhari-Jensen, daskmaje@hst.aau.dk
About this study
Official title: Understanding the Neural Mechanism Behind Sensory Processing Anomalies
To assess sensory processing anomalies in neurotypical children, children with autism spectrum disorder, and attention-deficit hyperactivity disorder, particularly within the vibrotactile and auditory sensory modalities.
Read the detailed description
Neurodevelopmental disorders, such as attention-deficit-hyperactivity disorder (ADHD) and autism spectrum disorder (ASD), have been associated with a high prevalence of sensory processing anomalies. With the update of the diagnostic manuals International Classification of Diseases eleventh revision (ICD-11) and Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V), more emphasis has been given to the sensory symptoms of both these disorders. The demand of reliable and valid quantitative measurements of sensory processing anomalies are therefore increasing as such metrics has the potential to assist clinical decision-making e.g., in (differential) diagnostics and treatment response evaluation and prediction. The present observational study focuses on auditory and tactile processing. Hearing and touch are two of the most frequency reported modalities in which individuals with ASD experience sensory anomalies. In addition, adequate auditory and tactile processing are presumed fundamental in the emergence of various social and cognitive functions such as the development of language. Elucidating the sensory symptoms by means of psychophysics, neuroimaging, and quantitative measures of peripheral sensory organs could elucidate the underlying (neuro)physiology of sensory anomalies in ASD and ADHD.
The present project aims to elucidate the physiological substrates of abnormal sensory processing by conducting a battery of tests in children with ASD, ADHD, and neurotypical children. First, a series of questionnaires will be administered to acquire a (clinical) description of the participants (Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V); Autism Quotient (AQ, child version); Childhood Behavioral Checklist (CBCL 6-16); ADHD-Ration Scale (ADHD-RS); Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2); Use of pharmacotherapy). A standardized caregiver-reported sensory profile questionnaire will serve as the primary outcome (Sensory Profile 2, Child version). Second, transiently evoked otoacoustic emissions will be measured in order to account for peripheral mechanisms of hearing as well as their contralateral suppression to measure efferent auditory system functioning. Third, a psychophysic task will be conducted for the purpose of estimating the just-noticeable difference to auditory loudness and vibrotactile displacement intensities followed by a subjective categorical loudness scale experiment. Finally, two electroencephalographic experiments will be performed: a frequency tagging paradigm with interspersed pitch oddballs and a classical sensory gating paradigm using vibrotactile stimuli and auditory clicks.
- Conditions
- Attention Deficit Hyperactivity Disorder, Autism Spectrum Disorder, Sensory Processing Disorder
- Being tested
- Discrimination Acuity test, Transiently Evoked Otoacoustic Emission, Questionnaires, Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V), Clinical tests of ASD
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discrimination Acuity testBehavioural
Estimating the just-noticeable difference of auditory loudness and vibrotactile displacement to fit a psychometric function for each modality with parameters: threshold, slope, sensitivity, and response criterion.
Transiently Evoked Otoacoustic EmissionDiagnostic test
Examination of integrity of outer hair cells in the inner ear; with and without contralateral suppression.
QuestionnairesOther
Caregiver questionnaires send to parents online to acquire demographic information Autism Quotient (AQ), Child Behavior Checklist (CBCL6-16), Sensory Profile 2 (SP-2).
Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V)Behavioural
Estimates intelligence quotient
Clinical tests of ASDDiagnostic test
Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2)
Electroencephalography (EEG) with auditory or vibrotactile stimuliOther
Two paradigms will be used: an auditory frequency tagging paradigm with interspersed pitch oddballs and a classical sensory gating paradigm with either vibrotactile stimuli or auditory clicks.
Clinical tests of ADHDDiagnostic test
ADHD-Rating Scale (ADHD-RS)
| Study group | Role | What they receive |
|---|---|---|
| Children with Autism Spectrum Disorder | Children with a confirmed diagnosis of autism spectrum disorder made by a qualified psychiatrist. Receives: Behavioral: Discrimination Acuity test; Diagnostic Test: Transiently Evoked Otoacoustic Emission; Other: Questionnaires; Behavioral: Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V); Diagnostic Test: Clinical tests of ASD; Other: Electroencephalography (EEG) with auditory or vibrotactile stimuli | |
| Children with Attention-Deficit Hyperactivity Disorder | Children with a confirmed diagnosis of attention-deficit hyperactivity disorder made by a qualified psychiatrist. Receives: Behavioral: Discrimination Acuity test; Diagnostic Test: Transiently Evoked Otoacoustic Emission; Other: Questionnaires; Behavioral: Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V); Other: Electroencephalography (EEG) with auditory or vibrotactile stimuli; Diagnostic Test: Clinical tests of ADHD | |
| Neurotypical children | Children without a known or presumed psychiatric diagnosis. Receives: Behavioral: Discrimination Acuity test; Diagnostic Test: Transiently Evoked Otoacoustic Emission; Other: Questionnaires; Behavioral: Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V); Other: Electroencephalography (EEG) with auditory or vibrotactile stimuli |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory Profile 2
Caregiver questionnaire to assess sensory anomalies
Measured: 8 minutes, answered within 1 month of the experimental session
Secondary outcomes (13)
Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V)
General intelligence quotient
Measured: 1 hour 15 minutes, conducted within 1 year of the experimental session
Autism Quotient (AQ, child version)
Questionnaire addressing autistic traits
Measured: 8 minutes, answered within 1 month of the experimental session
Childhood Behavioral Checklist (CBCL 6-16)
Questionnaire addressing various behaviors relevant to DSM-V
Measured: 15 minutes, answered within 1 month of the experimental session
ADHD-Ration Scale (ADHD-RS)
Questionnaire addressing behaviors related to severity of ADHD symptoms
Measured: 15 minutes, conducted within 1 year of the experimental session
Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2)
Questionnaire addressing behaviors related to severity of ASD symptoms
Measured: 1 hour, conducted within 1 year of the experimental session
Use of pharmacotherapy
Use of pharmacotherapy
Measured: At time of experimental session
Transiently Evoked Otoacoustic Emission (TEOAE)
Cochlear energy produced during the processing of a click sound using Titan (Interacoustics A/S, Denmark) measured in decibel (dB) above the noise floor (i.e., signal-to-noise ratio).
Measured: 2 minutes, during experimental session
Contralateral suppression of TEOAE
The suppression effect on the TEOAE during binaural stimulation. Here, constant contralateral broadband pink noise is applied simultaneous to a ipsilateral TEOAE measurement. Thus, the measurement is similar to a TEOAE but here the outcome measure is the difference score (i.e., suppression effect) of with/without contralateral stimulation.
Measured: 2 minutes, during experimental session
Categorical Loudness Scale
Identifying quiet threshold, loudness discomfort level, and a grading of sound intensities between (quiet threshold, soft, comfortable, loud, loudness discomfort level).
Measured: 5 minutes, during experimental session
Auditory Loudness Discrimination Acuity
The just-noticeable difference (JND) from a reference tone intensity (65 decibel sound pressure level (dBSPL), 250 ms, 1000 Hz at interval one) to a test tone (amplitude increase between 0-15 dBSPL at interval two). The unit of JND is the change in dBSLP relative to the reference tone (ΔdBSLP).
Measured: 5 minutes, during experimental session
Vibrotactile Displacement Discrimination Acuity
The just-noticeable difference (JND) from a reference displacement intensity (160 µm, 250 ms, 230 Hz at interval one) to a test tone (amplitude increase between 0-640 µm at interval two). The unit of JND is the change in µm relative to the reference displacement (Δµm).
Measured: 5 minutes, during experimental session
Electroencephalography, sensory gating paradigm with auditory and vibrotactile stimulation
Gating/suppression of components in the event-related potential (ERP), beta-band power, and inter-trial phase coherence during stimulation.
Measured: 30 minutes, during experimental session
Electroencephalography, frequency tagging with pitch oddball (two conditions)
Difference scores for half semi-tone oddball and four semi-tone oddball in pitch deviation.
- Frequency domain amplitude for the standard and oddball (1.6 and 8 Hz)
- Narrow-band filtered EEG amplitudes (1-17 Hz)
Measured: 7 minutes, during experimental session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start1 Nov 2023
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Collaborators
- North Denmark Region
- Responsible party
- Principal investigator, Daniel Skak Mazhari-Jensen, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234033
- Sponsor's protocol ID
- N-20200091
- Status last verified
- Jan 2024
- First submitted
- 7 Dec 2023
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Neural Mechanism Behind Sensory Processing Anomalies
- ClinicalTrials.gov ID
- NCT06234033
- Acronym / sponsor ID
- N-20200091
- Conditions
- Attention Deficit Hyperactivity Disorder, Autism Spectrum Disorder, Sensory Processing Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Collaborators
- North Denmark Region
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 31 Jan 2024 (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.
To assess sensory processing anomalies in neurotypical children, children with autism spectrum disorder, and attention-deficit hyperactivity disorder, particularly within the vibrotactile and auditory sensory modalities.
Detailed description
Neurodevelopmental disorders, such as attention-deficit-hyperactivity disorder (ADHD) and autism spectrum disorder (ASD), have been associated with a high prevalence of sensory processing anomalies. With the update of the diagnostic manuals International Classification of Diseases eleventh revision (ICD-11) and Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V), more emphasis has been given to the sensory symptoms of both these disorders. The demand of reliable and valid quantitative measurements of sensory processing anomalies are therefore increasing as such metrics has the potential to assist clinical decision-making e.g., in (differential) diagnostics and treatment response evaluation and prediction. The present observational study focuses on auditory and tactile processing. Hearing and touch are two of the most frequency reported modalities in which individuals with ASD experience sensory anomalies. In addition, adequate auditory and tactile processing are presumed fundamental in the emergence of various social and cognitive functions such as the development of language. Elucidating the sensory symptoms by means of psychophysics, neuroimaging, and quantitative measures of peripheral sensory organs could elucidate the underlying (neuro)physiology of sensory anomalies in ASD and ADHD.
The present project aims to elucidate the physiological substrates of abnormal sensory processing by conducting a battery of tests in children with ASD, ADHD, and neurotypical children. First, a series of questionnaires will be administered to acquire a (clinical) description of the participants (Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V); Autism Quotient (AQ, child version); Childhood Behavioral Checklist (CBCL 6-16); ADHD-Ration Scale (ADHD-RS); Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2); Use of pharmacotherapy). A standardized caregiver-reported sensory profile questionnaire will serve as the primary outcome (Sensory Profile 2, Child version). Second, transiently evoked otoacoustic emissions will be measured in order to account for peripheral mechanisms of hearing as well as their contralateral suppression to measure efferent auditory system functioning. Third, a psychophysic task will be conducted for the purpose of estimating the just-noticeable difference to auditory loudness and vibrotactile displacement intensities followed by a subjective categorical loudness scale experiment. Finally, two electroencephalographic experiments will be performed: a frequency tagging paradigm with interspersed pitch oddballs and a classical sensory gating paradigm using vibrotactile stimuli and auditory clicks.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Children with Autism Spectrum Disorder | – | Behavioral: Discrimination Acuity test, Diagnostic Test: Transiently Evoked Otoacoustic Emission, Other: Questionnaires, Behavioral: Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V), Diagnostic Test: Clinical tests of ASD, Other: Electroencephalography (EEG) with auditory or vibrotactile stimuliChildren with a confirmed diagnosis of autism spectrum disorder made by a qualified psychiatrist. |
| Children with Attention-Deficit Hyperactivity Disorder | – | Behavioral: Discrimination Acuity test, Diagnostic Test: Transiently Evoked Otoacoustic Emission, Other: Questionnaires, Behavioral: Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V), Other: Electroencephalography (EEG) with auditory or vibrotactile stimuli, Diagnostic Test: Clinical tests of ADHDChildren with a confirmed diagnosis of attention-deficit hyperactivity disorder made by a qualified psychiatrist. |
| Neurotypical children | – | Behavioral: Discrimination Acuity test, Diagnostic Test: Transiently Evoked Otoacoustic Emission, Other: Questionnaires, Behavioral: Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V), Other: Electroencephalography (EEG) with auditory or vibrotactile stimuliChildren without a known or presumed psychiatric diagnosis. |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population include three well-defined groups of subjects: 1. Children with a diagnosis of ASD from the local Child and Adolescent Psychiatry clinic. 2. Children with a diagnosis of ADHD from the local Child and Adolescent Psychiatry clinic. 3. Neurotypical children without any psychiatric or neurologic diagnosis.
Key inclusion criteria (2 listed)
- Clinically diagnosed with either ADHD, ASD, or no diagnosis (typical development)
- Between 8-15 years old
Key exclusion criteria (6 listed)
- Familiar history of schizophrenia and depression.
- Epilepsy, cerebral palsy, traumatic brain injury
- Musculoskeletal illnesses
- Hearing or visual impairment that cannot be corrected
- Lack of ability to cooperate
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 |
|---|---|---|
| Discrimination Acuity testEstimating the just-noticeable difference of auditory loudness and vibrotactile displacement to fit a psychometric function for each modality with parameters: threshold, slope, sensitivity, and response criterion. | Behavioural | Children with Attention-Deficit Hyperactivity Disorder, Children with Autism Spectrum Disorder, Neurotypical children |
| Transiently Evoked Otoacoustic EmissionExamination of integrity of outer hair cells in the inner ear; with and without contralateral suppression. | Diagnostic test | Children with Attention-Deficit Hyperactivity Disorder, Children with Autism Spectrum Disorder, Neurotypical children |
| QuestionnairesCaregiver questionnaires send to parents online to acquire demographic information Autism Quotient (AQ), Child Behavior Checklist (CBCL6-16), Sensory Profile 2 (SP-2). | Other | Children with Attention-Deficit Hyperactivity Disorder, Children with Autism Spectrum Disorder, Neurotypical children |
| Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V)Estimates intelligence quotient | Behavioural | Children with Attention-Deficit Hyperactivity Disorder, Children with Autism Spectrum Disorder, Neurotypical children |
| Clinical tests of ASDAutism Diagnostic Observation Schedule, 2nd edition (ADOS-2) | Diagnostic test | Children with Autism Spectrum Disorder |
| Electroencephalography (EEG) with auditory or vibrotactile stimuliTwo paradigms will be used: an auditory frequency tagging paradigm with interspersed pitch oddballs and a classical sensory gating paradigm with either vibrotactile stimuli or auditory clicks. | Other | Children with Attention-Deficit Hyperactivity Disorder, Children with Autism Spectrum Disorder, Neurotypical children |
| Clinical tests of ADHDADHD-Rating Scale (ADHD-RS) | Diagnostic test | Children with Attention-Deficit Hyperactivity Disorder |
Primary outcome
Sensory Profile 2
Time frame: 8 minutes, answered within 1 month of the experimental session
Caregiver questionnaire to assess sensory anomalies
13 secondary outcomes
Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V)
Time frame: 1 hour 15 minutes, conducted within 1 year of the experimental session
Autism Quotient (AQ, child version)
Time frame: 8 minutes, answered within 1 month of the experimental session
Childhood Behavioral Checklist (CBCL 6-16)
Time frame: 15 minutes, answered within 1 month of the experimental session
ADHD-Ration Scale (ADHD-RS)
Time frame: 15 minutes, conducted within 1 year of the experimental session
Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2)
Time frame: 1 hour, conducted within 1 year of the experimental session
Use of pharmacotherapy
Time frame: At time of experimental session
Transiently Evoked Otoacoustic Emission (TEOAE)
Time frame: 2 minutes, during experimental session
Contralateral suppression of TEOAE
Time frame: 2 minutes, during experimental session
Categorical Loudness Scale
Time frame: 5 minutes, during experimental session
Auditory Loudness Discrimination Acuity
Time frame: 5 minutes, during experimental session
Vibrotactile Displacement Discrimination Acuity
Time frame: 5 minutes, during experimental session
Electroencephalography, sensory gating paradigm with auditory and vibrotactile stimulation
Time frame: 30 minutes, during experimental session
Electroencephalography, frequency tagging with pitch oddball (two conditions)
Time frame: 7 minutes, during experimental session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- 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.
Daniel Skak Mazhari-Jensen contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Hyperactivity Disorder and Autism Spectrum Disorder, run by Aalborg University at 1 site in Denmark.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 31 Jan 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sabata Gervasio (9940 8820, saba@hst.aau.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensory Profile 2 (time frame: 8 minutes, answered within 1 month of the experimental session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2025.