Stimulant Medication Effects on Auditory Sensitivity and Acoustic Reflex in Adolescents With ADHD
| Registry | NCT04577417 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 70 (Actual) |
| Sponsor | Nemours Children's Clinic (Other) |
| Conditions | Attention Deficit Hyperactivity Disorder, Attention Deficit Disorder, Attention Deficit Disorder With Hyperactivity |
| Interventions | ADHD stimulants, for example, amphetamine, dexmethylphenidate, dextroamphetamine, methylphenidate (Drug) |
| Dates | start 2020-09-13, primary completion 2022-06-15, completion 2022-06-15, first posted 2020-10-06, last updated 2022-12-13 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Attention Deficit Hyperactivity Disorder All trials for Attention Deficit Disorder All trials of ADHD stimulants, for example, amphetamine, dexmethylphenidate, dextroamphetamine, methylphenidate
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.
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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| ADHD | Drug: 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 | |
| Control | Adolescents, male or female, ages 13-19, with normal health status and development |
Sex: All, ages: 13 Years to 19 Years, 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
| Facility | City | Country | Status |
|---|---|---|---|
| Nemours Children's Health | Wilmington, Delaware | United States |