Stimulant Medication Effects on Auditory Sensitivity in Teens With ADHD
- Conditions
- Attention Deficit Hyperactivity DisorderAttention Deficit DisorderAttention 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 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ADHD ADHD stimulants, for example, amphetamine, dexmethylphenidate, dextroamphetamine, methylphenidate 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
- Primary Outcome Measures
Name Time Method Acoustic reflex through study completion, an average of 1 year Acoustic reflex thresholds in each ear
Speech perception in noise through study completion, an average of 1 year Speech perception scores in each ear measured in two separate sessions
Loudness discomfort level through study completion, an average of 1 year Average loudness levels judged as uncomfortably loud sounds by each participant
- Secondary Outcome Measures
Name Time Method Otoacoustic emissions through study completion, an average of 1 year Measure of inner ear function
Fidgeting through study completion, an average of 1 year Measure of wrist movements during the testing
NIH Toolbox Cognition testing through study completion, an average of 1 year Measures of cognitive functions
Sensory profile questionnaire through study completion, an average of 1 year Sensory processing assessment
Tympanogram through study completion, an average of 1 year Results of tympanometry (type, volume, pressure, compliance, gradient) to measure middle ear function
Hearing screening through 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