Clinical trial NCT03216512: Effects of Noise Cancelling Headphones on Neurocognitive and Academic Outcomes in ADHD
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Bose Corporation
First posted: 2017-07-13
Enrollment: 36
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Proof-of-concept, randomized, within-subject cross-over design.
Primary purpose: OTHER

Brief 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.

Detailed description: 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.

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.

Primary outcomes:
measure: Change in CANTAB ADHD Battery - Motor Control Task
timeFrame: Baseline, experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1)
measure: Change in CANTAB ADHD Battery - Spatial Working Memory Task
timeFrame: Baseline, experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1)
measure: Change in CANTAB ADHD Battery - Stop Signal Reaction Time Task
timeFrame: Baseline, experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1)
measure: Change in CANTAB ADHD Battery - Rapid Visual Processing Task
timeFrame: Baseline, experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1)
Secondary outcomes:
measure: Change in Academic Productivity Measures -Math
timeFrame: Baseline, experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1)
measure: Subjective Reports of Experience
timeFrame: Experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1)
measure: Change in Academic Productivity Measures -Reading Comprehension
timeFrame: Baseline, experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Child and Family Study Center
state: North Carolina
Study officials:
References: