Stimulant Medication Effects on Auditory Sensitivity in Teens With ADHD

NCT04577417 | Completed DMC

• 1 other identifier: 1600804
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder; Attention Deficit Disorder; Attention Deficit Disorder With Hyperactivity

Keywords

stimulant medication

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Tympanogram

  through study completion, an average of 1 year

• Otoacoustic emissions

  through study completion, an average of 1 year

• NIH Toolbox Cognition testing

  through study completion, an average of 1 year

• Hearing screening

  through study completion, an average of 1 year

• Sensory profile questionnaire

  through study completion, an average of 1 year

Study Arms (2)

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

Control

Adolescents, male or female, ages 13-19, with normal health status and development

Interventions

ADHD stimulants, for example, amphetamine, dexmethylphenidate, dextroamphetamine, methylphenidate DRUG

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.

Also known as: Adderall, Focalin, Ritalin, Vyvanse, Concerta

ADHD

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adolescents with ADHD and typically developing adolescents

You may qualify if:

• Participant must be aged 13 to 19 years
• Males and females
• All ethnicities
• All socioeconomic statuses
• Normal hearing
• English as a primary language
• 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

You may not qualify if:

• 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)
• Treatment with any psychotropic medications other than stimulants
• Treatment with any ADHD medication other than stimulants (e.g. alpha-agonists, norepinephrine reuptake inhibitors)
• Treatment with any psychotropic medication

Sponsors & Collaborators

• Nemours Children's Clinic: lead

Study Sites (1)

Nemours Children's Health

Wilmington, Delaware, 19803, United States

Location

Related Publications (1)

• Sydenstricker S, Moore A, Nagao K. Comparison of Fidgeting in Adolescents with Attention-Deficit/Hyperactivity Disorder Between Before and After Stimulant Medication Intake. J Child Adolesc Psychopharmacol. 2023 May;33(4):143-148. doi: 10.1089/cap.2022.0080. Epub 2023 Mar 10.

  PMID: 36913518 DERIVED

Related Links

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

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Amphetamine; Dexmethylphenidate Hydrochloride; Dextroamphetamine; Methylphenidate; Adderall; Lisdexamfetamine Dimesylate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Kyoko Nagao, PhD

  Nemours

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: October 6, 2020
• Study Start: September 13, 2020
• Primary Completion: June 15, 2022
• Study Completion: June 15, 2022
• Last Updated: December 13, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)