Stimulant Medication Effects on Auditory Sensitivity in Teens With ADHD

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

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder; Attention Deficit Disorder With Hyperactivity; Attention Deficit Disorder
• Intervention / Treatment: Drug: ADHD stimulants, for example, amphetamine, dexmethylphenidate, dextroamphetamine, methylphenidate

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).

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

• Study Contact: Name: Shelby Sydenstricker, MA; Phone Number: 302-651-5963; Email: shelby.sydenstricker@nemours.org
• Study Contact Backup: Name: Kyoko Nagao, PhD; Phone Number: 302-651-6830; Email: kyoko.nagao@nemours.org

Study Locations

• United States
  • Delaware
    • Wilmington, Delaware, United States, 19803
      • Nemours Children's Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adolescents with ADHD and typically developing adolescents

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ADHD; 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; 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.; Other Names: Concerta; Vyvanse; Adderall; Ritalin; Focalin
Control; Adolescents, male or female, ages 13-19, with normal health status and development

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nemours Children's Clinic
• Investigators: Principal Investigator: Kyoko Nagao, PhD, Nemours

Publications and helpful links

Helpful Links

• Teenagers with ADHD may perceive loud sounds in a different way. Acoustical Society of America Press Room.

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2020
• Primary Completion (Actual): June 15, 2022
• Study Completion (Actual): June 15, 2022

Study Registration Dates

• First Submitted: September 18, 2020
• First Submitted That Met QC Criteria: October 2, 2020
• First Posted (Actual): October 6, 2020

Study Record Updates

• Last Update Posted (Estimate): December 13, 2022
• Last Update Submitted That Met QC Criteria: December 9, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: stimulant medication
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Disease; Attention Deficit Disorder with Hyperactivity; Hyperkinesis; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Sympathomimetics; Adrenergic Uptake Inhibitors; Methylphenidate; Amphetamine; Dextroamphetamine; Adderall; Dexmethylphenidate Hydrochloride
• Other Study ID Numbers: 1600804

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No