Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
75 participants
OBSERVATIONAL
2023-11-01
2025-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
EEG Studies of Sensory Processing in Autistic Children
NCT00319722
Auditory, Visual, and Tactile Interactions During Active, Dynamic Touch
NCT05943392
Emotional and Change-related Attention in Autism
NCT02160119
Neurophysiological Study of Sensory and Cognitive Processes in Healthy Children and Adults
NCT03182400
Activity of the Auditory Cortex During Speech Perception and Speech Production in Stuttering
NCT00148161
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Children with Autism Spectrum Disorder
Children with a confirmed diagnosis of autism spectrum disorder made by a qualified psychiatrist.
Discrimination Acuity test
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 Emission
Examination of integrity of outer hair cells in the inner ear; with and without contralateral suppression.
Questionnaires
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)
Estimates intelligence quotient
Clinical tests of ASD
Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2)
Electroencephalography (EEG) with auditory or vibrotactile stimuli
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.
Children with Attention-Deficit Hyperactivity Disorder
Children with a confirmed diagnosis of attention-deficit hyperactivity disorder made by a qualified psychiatrist.
Discrimination Acuity test
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 Emission
Examination of integrity of outer hair cells in the inner ear; with and without contralateral suppression.
Questionnaires
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)
Estimates intelligence quotient
Electroencephalography (EEG) with auditory or vibrotactile stimuli
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 ADHD
ADHD-Rating Scale (ADHD-RS)
Neurotypical children
Children without a known or presumed psychiatric diagnosis.
Discrimination Acuity test
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 Emission
Examination of integrity of outer hair cells in the inner ear; with and without contralateral suppression.
Questionnaires
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)
Estimates intelligence quotient
Electroencephalography (EEG) with auditory or vibrotactile stimuli
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Discrimination Acuity test
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 Emission
Examination of integrity of outer hair cells in the inner ear; with and without contralateral suppression.
Questionnaires
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)
Estimates intelligence quotient
Clinical tests of ASD
Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2)
Electroencephalography (EEG) with auditory or vibrotactile stimuli
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 ADHD
ADHD-Rating Scale (ADHD-RS)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Between 8-15 years old
Exclusion Criteria
* 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
8 Years
15 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
North Denmark Region
OTHER_GOV
Aalborg University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Daniel Skak Mazhari-Jensen
PhD-Fellow
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Health Science and Technology
Aalborg, North Denmark, Denmark
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Daniel Skak Mazhari-Jensen
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
N-20200091
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.