Stimulant Medication Effects on Auditory Sensitivity in Teens With ADHD

• ClinicalTrials.gov Identifier: NCT04577417
• Recruitment Status: Completed
• First Posted: October 6, 2020
• Last Update Posted: December 13, 2022
• Sponsor: Nemours Children's Clinic
• Information provided by (Responsible Party): Nemours Children's Clinic

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
Attention Deficit Hyperactivity Disorder; Attention Deficit Disorder; Attention Deficit Disorder With Hyperactivity	Drug: ADHD stimulants, for example, amphetamine, dexmethylphenidate, dextroamphetamine, methylphenidate

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

• Study Type: Observational
• Actual Enrollment: 70 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Stimulant Medication Effects on Auditory Sensitivity and Acoustic Reflex in Adolescents With ADHD
• Actual Study Start Date: September 13, 2020
• Actual Primary Completion Date: June 15, 2022
• Actual Study Completion Date: June 15, 2022

Groups and Cohorts

Group/Cohort	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: Adderall; Focalin; Ritalin; Vyvanse; Concerta
Control; Adolescents, male or female, ages 13-19, with normal health status and development

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 13 Years to 19 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Adolescents with ADHD and typically developing adolescents

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

Contacts and Locations

Locations

United States, Delaware

Nemours Children's Health

Wilmington, Delaware, United States, 19803

Sponsors and Collaborators

Nemours Children's Clinic

Investigators

• Principal Investigator: Kyoko Nagao, PhD; Nemours

More Information

Additional Information:

Teenagers with ADHD may perceive loud sounds in a different way. Acoustical Society of America Press Room. 

• Responsible Party: Nemours Children's Clinic
• ClinicalTrials.gov Identifier: NCT04577417
• Other Study ID Numbers: 1600804
• First Posted: October 6, 2020
• Last Update Posted: December 13, 2022
• Last Verified: December 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Nemours Children's Clinic:

stimulant medication

Additional relevant MeSH terms:

Hyperkinesis; Disease; Attention Deficit Disorder with Hyperactivity; Pathologic Processes; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Methylphenidate; Amphetamine; Adderall; Dextroamphetamine; Dexmethylphenidate Hydrochloride; Central Nervous System Stimulants; Physiological Effects of Drugs; Dopamine Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Dopamine Agents; Neurotransmitter Agents; Sympathomimetics; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agents; Adrenergic Uptake Inhibitors