N/A
N=31
Effects of Noise Cancelling Headphones on Neurocognitive and Academic Outcomes in ADHD
ADHD
Bottom Line
View on ClinicalTrials.gov: NCT03216512 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Change in CANTAB ADHD Battery - Motor Control Task — -0.033; -0.067 reaction time (ms)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Use of Noise Cancelling Headphones (Other)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in CANTAB ADHD Battery - Motor Control Task |
-0.033; -0.067 | — |
| PRIMARY Change in CANTAB ADHD Battery - Spatial Working Memory Task |
-3.28; -3.48 | — |
| PRIMARY Change in CANTAB ADHD Battery - Stop Signal Reaction Time Task |
117.56; 78.41 | — |
| PRIMARY Change in CANTAB ADHD Battery - Rapid Visual Processing Task |
-0.013; 0.001 | — |
| SECONDARY Change in Academic Productivity Measures -Math |
3.77; 0.87 | — |
| SECONDARY Subjective Reports of Experience |
6.53; 6.93 | — |
| SECONDARY Change in Academic Productivity Measures -Reading Comprehension |
0.33; -2.27 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03216512). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.