Stimulant Medication Effects on Auditory Sensitivity in Teens With ADHD

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

Stimulant Medication Effects on Auditory Sensitivity and Acoustic Reflex in Adolescents With ADHD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04577417
• Other study ID #: 1600804
• Status: Completed
• Start date: September 13, 2020
• Est. completion date: June 15, 2022

Study information

• Verified date: December 2022
• Source: Nemours Children's Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 15, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder
• Attention Deficit Disorder With Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Disease
• Hyperkinesis

Intervention

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.

Locations

Country	Name	City	State
United States	Nemours Children's Health	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Nemours Children's Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acoustic reflex	Acoustic reflex thresholds in each ear	through study completion, an average of 1 year
Primary	Loudness discomfort level	Average loudness levels judged as uncomfortably loud sounds by each participant	through study completion, an average of 1 year
Primary	Speech perception in noise	Speech perception scores in each ear measured in two separate sessions	through study completion, an average of 1 year
Secondary	Tympanogram	Results of tympanometry (type, volume, pressure, compliance, gradient) to measure middle ear function	through study completion, an average of 1 year
Secondary	Otoacoustic emissions	Measure of inner ear function	through study completion, an average of 1 year
Secondary	NIH Toolbox Cognition testing	Measures of cognitive functions	through study completion, an average of 1 year
Secondary	Hearing screening	Pure-tone hearing test to measure hearing sensitivity	through study completion, an average of 1 year
Secondary	Sensory profile questionnaire	Sensory processing assessment	through study completion, an average of 1 year
Secondary	Fidgeting	Measure of wrist movements during the testing	through study completion, an average of 1 year

External Links

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