Stimulant Medication Effects on Auditory Sensitivity and Acoustic Reflex in Adolescents With ADHD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Acoustic reflex
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 13 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: ADHD stimulants, for example, amphetamine, dexmethylphenidate, dextroamphetamine, methylphenidate (Drug)
结局指标
主要结局
Acoustic reflex
时间窗: through study completion, an average of 1 year
Acoustic reflex thresholds in each ear
Speech perception in noise
时间窗: through study completion, an average of 1 year
Speech perception scores in each ear measured in two separate sessions
Loudness discomfort level
时间窗: through study completion, an average of 1 year
Average loudness levels judged as uncomfortably loud sounds by each participant
次要结局
- Otoacoustic emissions(through study completion, an average of 1 year)
- Fidgeting(through study completion, an average of 1 year)
- NIH Toolbox Cognition testing(through study completion, an average of 1 year)
- Sensory profile questionnaire(through study completion, an average of 1 year)
- Tympanogram(through study completion, an average of 1 year)
- Hearing screening(through study completion, an average of 1 year)