Effects of Noise Cancelling Headphones on Neurocognitive and Academic Outcomes in ADHD
Completed · Not applicable · Has a placebo group
Conditions studied: ADHD
In brief
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.
Key facts
- Study ID
- NCT03216512
- Run by
- Duke University
- People needed
- 36
- Starts
- 2018-09-21
- Expected to finish
- 2019-01-31
- Last updated by the study team
- 2020-01-18
Who can join
Age: 6 and older, up to 17. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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 ≥24.
- Estimated IQ (measured with the KBIT-2) ≥80.
- 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.
You may not qualify if…
- 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.
Where it is running
- Duke Child and Family Study Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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