Attention Deficit Hyperactivity DisorderNCT04577417
Stimulant Medication Effects on Auditory Sensitivity in Teens With ADHD
An observational study of Attention Deficit Hyperactivity Disorder and Attention Deficit Disorder, run by Nemours Children's Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder, Attention Deficit Disorder, Attention Deficit Disorder With Hyperactivity
- What is being tested?
- ADHD stimulants, for example, amphetamine, dexmethylphenidate, dextroamphetamine, methylphenidate
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2020to 15 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Adolescents with ADHD and typically developing adolescents
Who may be able to join
- Participant must be aged 13 to 19 years
- Males and females
- All ethnicities
- All socioeconomic statuses
- Normal hearing
- English as a primary language
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Nemours Children's Health
Wilmington, Delaware, 19803
About this study
Official title: Stimulant Medication Effects on Auditory Sensitivity and Acoustic Reflex in Adolescents With ADHD
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.
Read the 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).
- Conditions
- Attention Deficit Hyperactivity Disorder, Attention Deficit Disorder, Attention Deficit Disorder With Hyperactivity
- Being tested
- ADHD stimulants, for example, amphetamine, dexmethylphenidate, dextroamphetamine, methylphenidate
- Keywords
- stimulant medication
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADHD stimulants, for example, amphetamine, dexmethylphenidate, dextroamphetamine, methylphenidateDrug
Also called Adderall, Focalin, Ritalin, Vyvanse
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: ADHD stimulants, for example, amphetamine, dexmethylphenidate, dextroamphetamine, methylphenidate | |
| Control | Adolescents, male or female, ages 13-19, with normal health status and development |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acoustic reflex
Acoustic reflex thresholds in each ear
Measured: through study completion, an average of 1 year
Loudness discomfort level
Average loudness levels judged as uncomfortably loud sounds by each participant
Measured: through study completion, an average of 1 year
Speech perception in noise
Speech perception scores in each ear measured in two separate sessions
Measured: through study completion, an average of 1 year
Secondary outcomes (6)
Tympanogram
Results of tympanometry (type, volume, pressure, compliance, gradient) to measure middle ear function
Measured: through study completion, an average of 1 year
Otoacoustic emissions
Measure of inner ear function
Measured: through study completion, an average of 1 year
NIH Toolbox Cognition testing
Measures of cognitive functions
Measured: through study completion, an average of 1 year
Hearing screening
Pure-tone hearing test to measure hearing sensitivity
Measured: through study completion, an average of 1 year
Sensory profile questionnaire
Sensory processing assessment
Measured: through study completion, an average of 1 year
Fidgeting
Measure of wrist movements during the testing
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start13 Sep 2020
- Primary completion15 Jun 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kyoko Nagao, PhD, Principal investigator, Nemours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04577417
- Sponsor's protocol ID
- 1600804
- Status last verified
- Dec 2022
- First submitted
- 18 Sep 2020
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sydenstricker S, Moore A, Nagao K. Comparison of Fidgeting in Adolescents with Attention-Deficit/Hyperactivity Disorder Between Before and After Stimulant Medication Intake. J Child Adolesc Psychopharmacol. 2023 May;33(4):143-148. doi: 10.1089/cap.2022.0080. Epub 2023 Mar 10.
PubMed 36913518
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulant Medication Effects on Auditory Sensitivity and Acoustic Reflex in Adolescents With ADHD
- ClinicalTrials.gov ID
- NCT04577417
- Acronym / sponsor ID
- 1600804
- Conditions
- Attention Deficit Hyperactivity Disorder, Attention Deficit Disorder, Attention Deficit Disorder With Hyperactivity
- Keywords
- stimulant medication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Study start
- 13 Sep 2020 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 6 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADHD | – | Drug: ADHD stimulants, for example, amphetamine, dexmethylphenidate, dextroamphetamine, methylphenidateAdolescents, 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 |
| Control | – | –Adolescents, male or female, ages 13-19, with normal health status and development |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Adolescents with ADHD and typically developing adolescents
Key inclusion criteria (9 listed)
- Participant must be aged 13 to 19 years
- Males and females
- All ethnicities
- All socioeconomic statuses
- Normal hearing
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADHD stimulants, for example, amphetamine, dexmethylphenidate, dextroamphetamine, methylphenidateAlso: Adderall, Focalin, Ritalin, VyvanseBoth 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. | Drug | ADHD |
Primary outcome
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
6 secondary outcomes
Tympanogram
Time frame: through study completion, an average of 1 year
Otoacoustic emissions
Time frame: through study completion, an average of 1 year
NIH Toolbox Cognition testing
Time frame: through study completion, an average of 1 year
Hearing screening
Time frame: through study completion, an average of 1 year
Sensory profile questionnaire
Time frame: through study completion, an average of 1 year
Fidgeting
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
- Derived from this study: PubMed 36913518Sydenstricker S, Moore A, Nagao K. Comparison of Fidgeting in Adolescents with Attention-Deficit/Hyperactivity Disorder Between Before and After Stimulant Medication Intake. J Child Adolesc Psychopharmacol. 2023 May;33(4):143-148. doi: 10.1089/cap.2022.0080. Epub 2023 Mar 10.
- Teenagers with ADHD may perceive loud sounds in a different way. Acoustical Society of America Press Room.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyoko Nagao, PhD principal investigator
Nemours
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Hyperactivity Disorder and Attention Deficit Disorder, run by Nemours Children's Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acoustic reflex (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04577417, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2022.