Stimulant Medication Effects on Auditory Sensitivity in Teens With ADHD

Nemours Children's Health

Status: Completed

Conditions: Attention Deficit Disorder; Attention Deficit Hyperactivity Disorder; Attention Deficit Disorder With Hyperactivity

Treatments: Drug: ADHD stimulants, for example, amphetamine, dexmethylphenidate, dextroamphetamine, methylphenidate

Study type: Observational

Funder types: Other

Identifiers

NCT04577417

1600804

Details and patient eligibility

About

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.

Full 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).

Enrollment: 70 patients

Sex: All

Ages: 13 to 19 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

70 participants in 2 patient groups

ADHD

Description:

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

Treatment:

Drug: ADHD stimulants, for example, amphetamine, dexmethylphenidate, dextroamphetamine, methylphenidate

Control

Description:

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