Clinical trial NCT04577417: Stimulant Medication Effects on Auditory Sensitivity in Teens With ADHD
Official title: Stimulant Medication Effects on Auditory Sensitivity and Acoustic Reflex in Adolescents With ADHD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Attention Deficit Hyperactivity Disorder
Attention Deficit Disorder
Attention Deficit Disorder With Hyperactivity
Keywords: stimulant medication
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
First posted: 2020-10-06
Enrollment: 70
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents with ADHD and typically developing adolescents

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).

Eligibility criteria: 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

Primary outcomes:
measure: Acoustic reflex
timeFrame: through study completion, an average of 1 year
measure: Loudness discomfort level
timeFrame: through study completion, an average of 1 year
measure: Speech perception in noise
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Tympanogram
timeFrame: through study completion, an average of 1 year
measure: Otoacoustic emissions
timeFrame: through study completion, an average of 1 year
measure: NIH Toolbox Cognition testing
timeFrame: through study completion, an average of 1 year
measure: Hearing screening
timeFrame: through study completion, an average of 1 year
measure: Sensory profile questionnaire
timeFrame: through study completion, an average of 1 year
measure: Fidgeting
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Nemours Children's Health
state: Delaware
Study officials:
affiliation: Nemours
name: Kyoko Nagao, PhD
role: PRINCIPAL_INVESTIGATOR
References: