Stimulant Medication Effects on Auditory Sensitivity in Teens With ADHD (NCT04577417) | Clinical Trial Compass
CompletedNot Applicable
Stimulant Medication Effects on Auditory Sensitivity in Teens With ADHD
United States70 participantsStarted 2020-09-13
Plain-language summary
The aims of this study are to evaluate auditory sensitivity in teenagers with ADHD using acoustic reflex thresholds (ART) and to examine the effects of ADHD stimulant medication on ART.
Who can participate
Age range13 Years – 19 Years
SexALL
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Inclusion Criteria:
Inclusion criteria for all:
* Participant must be aged 13 to 19 years
* Males and females
* All ethnicities
* All socioeconomic statuses
* Normal hearing
* English as a primary language
Additional inclusion criteria for ADHD group:
* Participants must meet diagnostic criteria for attention-deficit/hyperactivity disorder (ADHD), all subtypes, based on the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
* Stimulant medication with the same drug and dosage for at least 1 year before their enrollment date
Exclusion Criteria:
* History of any major neurological disorders (e.g. seizures excluding febrile seizure under age 6 years, tumors, brain injury, cerebral palsy, tic disorders)
* History of any other major neuropsychiatric disorders (e.g. autism spectrum disorder, mood dysregulation),
* Presence of pressure equalization tubes in either ear
* Documented hearing impairment 20 decibel or higher hearing loss in either ear
* Estimated low cognitive function based on the NIH Toolbox Cognition age-corrected scores (\<70)
Additional exclusion criteria for the ADHD group
* Treatment with any psychotropic medications other than stimulants
* Treatment with any ADHD medication other than stimulants (e.g. alpha-agonists, norepinephrine reuptake inhibitors)
Additional exclusion criteria for the control group
• Treatment with any psychotropic medication
What they're measuring
1
Acoustic reflex
Timeframe: through study completion, an average of 1 year
2
Loudness discomfort level
Timeframe: through study completion, an average of 1 year
3
Speech perception in noise
Timeframe: through study completion, an average of 1 year