MedPath

Stimulant Medication Effects on Auditory Sensitivity in Teens With ADHD

Completed
Conditions
Attention Deficit Hyperactivity Disorder
Attention Deficit Disorder
Attention Deficit Disorder With Hyperactivity
Interventions
Registration Number
NCT04577417
Lead Sponsor
Nemours Children's Clinic
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).

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
70
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
Read More
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

Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
ADHDADHD stimulants, for example, amphetamine, dexmethylphenidate, dextroamphetamine, methylphenidateAdolescents, 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
Primary Outcome Measures
NameTimeMethod
Acoustic reflexthrough study completion, an average of 1 year

Acoustic reflex thresholds in each ear

Speech perception in noisethrough study completion, an average of 1 year

Speech perception scores in each ear measured in two separate sessions

Loudness discomfort levelthrough study completion, an average of 1 year

Average loudness levels judged as uncomfortably loud sounds by each participant

Secondary Outcome Measures
NameTimeMethod
Otoacoustic emissionsthrough study completion, an average of 1 year

Measure of inner ear function

Fidgetingthrough study completion, an average of 1 year

Measure of wrist movements during the testing

NIH Toolbox Cognition testingthrough study completion, an average of 1 year

Measures of cognitive functions

Sensory profile questionnairethrough study completion, an average of 1 year

Sensory processing assessment

Tympanogramthrough study completion, an average of 1 year

Results of tympanometry (type, volume, pressure, compliance, gradient) to measure middle ear function

Hearing screeningthrough study completion, an average of 1 year

Pure-tone hearing test to measure hearing sensitivity

Trial Locations

Locations (1)

Nemours Children's Health

🇺🇸

Wilmington, Delaware, United States

© Copyright 2025. All Rights Reserved by MedPath