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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04577417
Other study ID # 1600804
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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