Stimulant Medication Effects on Auditory Sensitivity in Teens With ADHD
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| ADHD 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 |
Drug: ADHD stimulants, for example, amphetamine, dexmethylphenidate, dextroamphetamine, methylphenidate
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:
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| Control Adolescents, male or female, ages 13-19, with normal health status and development |
Outcome Measures
Primary Outcome Measures
- Acoustic reflex [through study completion, an average of 1 year]
Acoustic reflex thresholds in each ear
- Loudness discomfort level [through study completion, an average of 1 year]
Average loudness levels judged as uncomfortably loud sounds by each participant
- Speech perception in noise [through study completion, an average of 1 year]
Speech perception scores in each ear measured in two separate sessions
Secondary Outcome Measures
- Tympanogram [through study completion, an average of 1 year]
Results of tympanometry (type, volume, pressure, compliance, gradient) to measure middle ear function
- Otoacoustic emissions [through study completion, an average of 1 year]
Measure of inner ear function
- NIH Toolbox Cognition testing [through study completion, an average of 1 year]
Measures of cognitive functions
- Hearing screening [through study completion, an average of 1 year]
Pure-tone hearing test to measure hearing sensitivity
- Sensory profile questionnaire [through study completion, an average of 1 year]
Sensory processing assessment
- Fidgeting [through study completion, an average of 1 year]
Measure of wrist movements during the testing
Eligibility Criteria
Criteria
Inclusion Criteria:
Inclusion criteria for all:
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Participant must be aged 13 to 19 years
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Males and females
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All ethnicities
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All socioeconomic statuses
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Normal hearing
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English as a primary language
Additional inclusion criteria for ADHD group:
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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)
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Stimulant medication with the same drug and dosage for at least 1 year before their enrollment date
Exclusion Criteria:
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History of any major neurological disorders (e.g. seizures excluding febrile seizure under age 6 years, tumors, brain injury, cerebral palsy, tic disorders)
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History of any other major neuropsychiatric disorders (e.g. autism spectrum disorder, mood dysregulation),
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Presence of pressure equalization tubes in either ear
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Documented hearing impairment 20 decibel or higher hearing loss in either ear
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Estimated low cognitive function based on the NIH Toolbox Cognition age-corrected scores (<70)
Additional exclusion criteria for the ADHD group
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Treatment with any psychotropic medications other than stimulants
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nemours Children's Health | Wilmington | Delaware | United States | 19803 |
Sponsors and Collaborators
- Nemours Children's Clinic
Investigators
- Principal Investigator: Kyoko Nagao, PhD, Nemours
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1600804