Stimulant Medication Effects on Auditory Sensitivity in Teens With ADHD

Study Overview
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Brief Summary
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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.

Detailed Description
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Attention-deficit/hyperactivity disorder (ADHD) is the most common neurodevelopmental disorder in children. Besides core ADHD symptoms (inattentiveness, hyperactivity, impulsivity), ADHD also affects the ability to perceive and process sounds. Both hypersensitivity and hyposensitivity to loud sounds are common symptoms in ADHD patients. With stimulant medication, individuals with ADHD become more tolerant of loud noise than when they were non-medicated. It remains unknown exactly how stimulant medication alters the loudness perception. The proposed study will use the acoustic reflex to objectively measure auditory sensitivity to loud sounds. The aims of this study are to evaluate auditory sensitivity in patients with ADHD using acoustic reflex thresholds (ART) and to examine the effects of ADHD stimulant medication on ART. Eligible participants will participate in two sessions (off-med and on-med conditions) conducted on the same day. ADHD patients will be asked to come to the laboratory before taking their ADHD medication. The investigators will repeat three tests before and after taking stimulant medication. The investigators will also conduct screening tests during and between the first and second sessions. The investigators will compare a difference between the two independent groups (ADHD vs. Control) and compare a within subject difference between medication conditions (on-med vs. off-med).

Official Title
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Stimulant Medication Effects on Auditory Sensitivity and Acoustic Reflex in Adolescents With ADHD

Conditions
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Attention Deficit Hyperactivity Disorder, Attention Deficit Disorder, Attention Deficit Disorder With Hyperactivity

Intervention / Treatment
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* Drug: ADHD stimulants, for example, amphetamine, dexmethylphenidate, dextroamphetamine, methylphenidate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ADHD<br>Adolescents, male or female, ages 13-19, diagnosed with ADHD, all subtypes, based on the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and under treatment with a stimulant medication with the same drug and dosage for at least 12 months before their study participation date | Drug: ADHD stimulants, for example, amphetamine, dexmethylphenidate, dextroamphetamine, methylphenidate<br>* Both ADHD and control groups of subjects will participate in 2 sessions (on-med and off-med conditions) conducted on the same day. ADHD group will be asked to come to the laboratory in the morning before taking their morning ADHD stimulant medication. They will be tested before and after taking their ADHD medication (off-med and on-med conditions). The investigators will observe changes between the two conditions.<br>* Other names: Concerta;|
| Control<br>Adolescents, male or female, ages 13-19, with normal health status and development | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acoustic reflex | Acoustic reflex thresholds in each ear | through study completion, an average of 1 year | 
| Loudness discomfort level | Average loudness levels judged as uncomfortably loud sounds by each participant | through study completion, an average of 1 year | 
| Speech perception in noise | Speech perception scores in each ear measured in two separate sessions | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tympanogram | Results of tympanometry (type, volume, pressure, compliance, gradient) to measure middle ear function | through study completion, an average of 1 year | 
| Otoacoustic emissions | Measure of inner ear function | through study completion, an average of 1 year | 
| NIH Toolbox Cognition testing | Measures of cognitive functions | through study completion, an average of 1 year | 
| Hearing screening | Pure-tone hearing test to measure hearing sensitivity | through study completion, an average of 1 year | 
| Sensory profile questionnaire | Sensory processing assessment | through study completion, an average of 1 year | 
| Fidgeting | Measure of wrist movements during the testing | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stimulant medication