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Stimulant Medication Effects on Auditory Sensitivity in Teens With ADHD

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

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).

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Study Type : Observational
Estimated Enrollment : 50 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
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

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



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



Information from the National Library of Medicine

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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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04577417


Contacts
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Contact: Shelby Sydenstricker, MA 302-651-5963 shelby.sydenstricker@nemours.org
Contact: Kyoko Nagao, PhD 302-651-6830 kyoko.nagao@nemours.org

Locations
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United States, Delaware
Nemours Children's Health Recruiting
Wilmington, Delaware, United States, 19803
Contact: Shelby Sydenstricker, MA    302-651-5963    shelby.sydenstricker@nemours.org   
Principal Investigator: Kyoko Nagao, PhD         
Sponsors and Collaborators
Nemours Children's Clinic
Investigators
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Principal Investigator: Kyoko Nagao, PhD Nemours
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Responsible Party: Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT04577417    
Other Study ID Numbers: 1600804
First Posted: October 6, 2020    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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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