A Randomized, Sham-Controlled, Crossover Study to Evaluate the Effects of Noise Cancelling Headphones on Neurocognitive and Academic Outcomes in Children and Adolescents Diagnosed With Attention Deficit Hyperactivity Disorder (ADHD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change in CANTAB ADHD Battery - Motor Control Task
研究概览
简要总结
The purpose of this study is to evaluate performance on the Attention Deficit Hyperactivity Disorder ( ADHD) Battery of the Cambridge Automated Neuropsychological Test Battery (CANTAB), including spatial working memory, inhibitory control, and attention while using either a noise cancelling headphone or sham headphone control in the presence of standardized auditory distractors in children and adolescents with ADHD.
详细描述
This will be a proof-of-concept, randomized, within-subject cross-over design with the administration of noise cancelling headphones or sham headphones on two separate study days. Following screening and a baseline assessment session with no headphones, participants will be assigned to complete each experimental session. During each session, they will undergo the CANTAB and Academic tasks. The order of sessions will be randomized and balanced across participants to be either noise-cancelling headphones first followed by sham headphones; or sham headphones first followed by noise-cancelling headphones. Eligible participants currently taking stimulant medications for ADHD will be asked to stop taking their medication on the day of the baseline visit and during the 2 experimental sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
The participant won't know whether they are receiving the noise cancelling headphones or the sham control.
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 6 to 17 at the time of parental informed consent.
- •Male or female.
- •Confirmed ADHD diagnosis at screening visit established via MINI-KID (version 7.0.2) administered by a trained clinician.
- •Screening ADHD-RS-IV score ≥
- •Estimated IQ (measured with the KBIT-2) ≥
- •If currently medicated with a stimulant medication (amphetamine or methylphenidate formulation), off drug on day of Baseline and Experimental Sessions. May resume medication after all assessments are completed on these days.
- •Able to follow written and verbal instructions (English) as assessed by the PI and/or study coordinator.
- •Able to comply with all testing and requirements.
排除标准
- •Current controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis, based on MINI-KID and subsequent clinical interviewing, with significant symptoms including but not limited to post-traumatic stress disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive-compulsive disorder, severe depressive or anxiety disorder, conduct disorder, or other symptomatic manifestations that in the opinion of the Investigator may confound study data/assessments (Participants with clinical history of learning disorders will be allowed to participate as long as the disorder does not impact their ability to participate based on PI judgement).
- •Current treatment with any non-stimulant medication for ADHD (e.g., atomoxetine, clonidine, guanfacine).
- •Current treatment with other psychoactive drugs.
- •Participant is currently considered at risk for attempting suicide by the Investigator, or is currently demonstrating active suicidal ideation or self-injurious behavior, as measured by MINI-KID Suicidality Module C.
- •Documented hearing loss.
- •Recent history or suspicion (within the past 6 months) of substance abuse or dependence.
- •Any other medical condition that, in the opinion of the Investigator, may confound study data/assessments.
结局指标
主要结局
Change in CANTAB ADHD Battery - Motor Control Task
时间窗: Baseline, experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1)
Compare change from Baseline scores on the Cambridge Automated Neuropsychological Test Battery (CANTAB) ADHD battery with noise cancelling headphones and sham-controls. Results are reported as change from Baseline for each of 4 components of the ADHD battery. Motor Control Task: no minimum and maximum values as values are reaction times; positive scores indicate slower reaction times compared to baseline; lower scores indicate faster reaction times compared to Baseline
Change in CANTAB ADHD Battery - Stop Signal Reaction Time Task
时间窗: Baseline, experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1)
Compare change from Baseline scores on the Cambridge Automated Neuropsychological Test Battery (CANTAB) ADHD battery with noise cancelling headphones and sham-controls. Results are reported as change from Baseline for each of 4 components of the ADHD battery. Stop Signal Reaction Time Task: no minimum and maximum values as values are reaction times; higher scores indicate worse performance compared to Baseline
Change in CANTAB ADHD Battery - Rapid Visual Processing Task
时间窗: Baseline, experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1)
Compare change from Baseline scores on the Cambridge Automated Neuropsychological Test Battery (CANTAB) ADHD battery with noise cancelling headphones and sham-controls. Results are reported as change from Baseline for each of 4 components of the ADHD battery. Rapid Visual Processing Task: no minimum and maximum values as values are number of correct hits; higher scores indicate better performance compared to Baseline
Change in CANTAB ADHD Battery - Spatial Working Memory Task
时间窗: Baseline, experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1)
Compare change from Baseline scores on the Cambridge Automated Neuropsychological Test Battery (CANTAB) ADHD battery with noise cancelling headphones and sham-controls. Results are reported as change from Baseline for each of 4 components of the ADHD battery. Spatial Working Memory Task: no minimum and maximum values as values are number of errors; higher (positive) scores indicate more errors compared to Baseline
次要结局
- Change in Academic Productivity Measures -Math(Baseline, experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1))
- Subjective Reports of Experience(Experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1))
- Change in Academic Productivity Measures -Reading Comprehension(Baseline, experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1))