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Completed

NCT Number: NCT04577417

Stimulant Medication Effects on Auditory Sensitivity in Teens 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.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder Attention Deficit Disorder With Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

13 year–19 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nemours Children's Health

Wilmington, Delaware, 19803, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Adderall, Focalin, Ritalin, Vyvanse, Concerta

Primary outcomes

  1. Acoustic reflex

    Time frame: through study completion, an average of 1 year

    Acoustic reflex thresholds in each ear

  2. Loudness discomfort level

    Time frame: through study completion, an average of 1 year

    Average loudness levels judged as uncomfortably loud sounds by each participant

  3. Speech perception in noise

    Time frame: through study completion, an average of 1 year

    Speech perception scores in each ear measured in two separate sessions

Secondary outcomes

  1. Tympanogram

    Time frame: through study completion, an average of 1 year

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

  2. Otoacoustic emissions

    Time frame: through study completion, an average of 1 year

    Measure of inner ear function

  3. NIH Toolbox Cognition testing

    Time frame: through study completion, an average of 1 year

    Measures of cognitive functions

  4. Hearing screening

    Time frame: through study completion, an average of 1 year

    Pure-tone hearing test to measure hearing sensitivity

  5. Sensory profile questionnaire

    Time frame: through study completion, an average of 1 year

    Sensory processing assessment

  6. Fidgeting

    Time frame: through study completion, an average of 1 year

    Measure of wrist movements during the testing

Sponsors and collaborators

Lead sponsor

Nemours Children's Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 6, 2020
Registry last updated
Dec 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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