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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

Tracking Information
First Submitted Date September 18, 2020
First Posted Date October 6, 2020
Last Update Posted Date October 6, 2020
Actual Study Start Date September 13, 2020
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 2, 2020)
  • Acoustic reflex [ Time Frame: through study completion, an average of 1 year ]
    Acoustic reflex thresholds in each ear
  • Loudness discomfort level [ Time Frame: through study completion, an average of 1 year ]
    Average loudness levels judged as uncomfortably loud sounds by each participant
  • 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: October 2, 2020)
  • Tympanogram [ Time Frame: through study completion, an average of 1 year ]
    Results of tympanometry (type, volume, pressure, compliance, gradient) to measure middle ear function
  • Otoacoustic emissions [ Time Frame: through study completion, an average of 1 year ]
    Measure of inner ear function
  • NIH Toolbox Cognition testing [ Time Frame: through study completion, an average of 1 year ]
    Measures of cognitive functions
  • Hearing screening [ Time Frame: through study completion, an average of 1 year ]
    Pure-tone hearing test to measure hearing sensitivity
  • Sensory profile questionnaire [ Time Frame: through study completion, an average of 1 year ]
    Sensory processing assessment
  • Fidgeting [ Time Frame: through study completion, an average of 1 year ]
    Measure of wrist movements during the testing
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Stimulant Medication Effects on Auditory Sensitivity in Teens With ADHD
Official Title Stimulant Medication Effects on Auditory Sensitivity and Acoustic Reflex in Adolescents With ADHD
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adolescents with ADHD and typically developing adolescents
Condition
  • Attention Deficit Hyperactivity Disorder
  • Attention Deficit Disorder
  • Attention Deficit Disorder With Hyperactivity
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.
Other Names:
  • Adderall
  • Focalin
  • Ritalin
  • Vyvanse
  • Concerta
Study Groups/Cohorts
  • 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
    Intervention: Drug: ADHD stimulants, for example, amphetamine, dexmethylphenidate, dextroamphetamine, methylphenidate
  • Control
    Adolescents, male or female, ages 13-19, with normal health status and development
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 2, 2020)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: All
Ages 13 Years to 19 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Shelby Sydenstricker, MA 302-651-5963 shelby.sydenstricker@nemours.org
Contact: Kyoko Nagao, PhD 302-651-6830 kyoko.nagao@nemours.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04577417
Other Study ID Numbers 1600804
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Nemours Children's Clinic
Study Sponsor Nemours Children's Clinic
Collaborators Not Provided
Investigators
Principal Investigator: Kyoko Nagao, PhD Nemours
PRS Account Nemours Children's Clinic
Verification Date September 2020