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

NCT03216512 | Completed Results FDA Device

• 1 other identifier: Pro00084739
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Outcome Measures

Primary Outcomes (4)

• Change in CANTAB ADHD Battery - Motor Control Task

  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

  Baseline, experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1)

• Change in CANTAB ADHD Battery - Spatial Working Memory Task

  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

  Baseline, experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1)

• Change in CANTAB ADHD Battery - Stop Signal Reaction Time Task

  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

  Baseline, experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1)

• Change in CANTAB ADHD Battery - Rapid Visual Processing Task

  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

  Baseline, experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1)

Secondary Outcomes (3)

• 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)

Study Arms (2)

Noise cancelling headphone first, then sham control headphone

EXPERIMENTAL

This group will use the noise cancelling headphone during the first experimental session as they complete study assessments. They will then return within a week, for experimental session day 2, to complete the same assessments this time using a sham control headphone.

Other: Use of Noise Cancelling Headphones

Sham control headphone first, then noise cancelling headphone

EXPERIMENTAL

This group will use the sham control headphone during the first experimental session as they complete study assessments. They will then return within a week for experimental session day 2, to redo the same assessments this time using a noise cancelling headphone.

Other: Use of Noise Cancelling Headphones

Interventions

Use of Noise Cancelling Headphones OTHER

During the 2 experimental sessions, participants will complete study assessments using either a noise cancelling headphone first (session 1) and then sham control second ( session 2), or vice versa, in the presence of noise distractions.

Noise cancelling headphone first, then sham control headphone; Sham control headphone first, then noise cancelling headphone

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Duke University: lead
• Bose Corporation: collaborator

Study Sites (1)

Duke Child and Family Study Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Dr Scott Kollins
• Organization: Duke University

scott.kollins@duke.edu

919-681-0014

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participant won't know whether they are receiving the noise cancelling headphones or the sham control.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Proof-of-concept, randomized, within-subject cross-over design.

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: July 13, 2017
• Study Start: September 21, 2018
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: January 18, 2020
• Results First Posted: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)