Effects of Noise Cancelling Headphones on Neurocognitive and Academic Outcomes in ADHD

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.

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.