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Stimulant Medication Effects on Auditory Sensitivity in Teens With ADHD

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04577417
Enrollment
70
Registered
2020-10-06
Start date
2020-09-13
Completion date
2022-06-15
Last updated
2022-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

stimulant medication

Brief 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.

Detailed description

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).

Interventions

DRUGADHD stimulants, for example, amphetamine, dexmethylphenidate, dextroamphetamine, methylphenidate

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.

Sponsors

Nemours Children's Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
13 Years to 19 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Acoustic reflexthrough study completion, an average of 1 yearAcoustic reflex thresholds in each ear
Loudness discomfort levelthrough study completion, an average of 1 yearAverage loudness levels judged as uncomfortably loud sounds by each participant
Speech perception in noisethrough study completion, an average of 1 yearSpeech perception scores in each ear measured in two separate sessions

Secondary

MeasureTime frameDescription
Tympanogramthrough study completion, an average of 1 yearResults of tympanometry (type, volume, pressure, compliance, gradient) to measure middle ear function
Otoacoustic emissionsthrough study completion, an average of 1 yearMeasure of inner ear function
NIH Toolbox Cognition testingthrough study completion, an average of 1 yearMeasures of cognitive functions
Hearing screeningthrough study completion, an average of 1 yearPure-tone hearing test to measure hearing sensitivity
Sensory profile questionnairethrough study completion, an average of 1 yearSensory processing assessment
Fidgetingthrough study completion, an average of 1 yearMeasure of wrist movements during the testing

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026