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

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)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03216512

Enrollment

Registered

2017-07-13

Start date

2018-09-21

Completion date

2019-01-31

Last updated

2020-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD

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.

Interventions

OTHERUse of Noise Cancelling Headphones

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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

SINGLE (Subject)

Masking description

The participant won't know whether they are receiving the noise cancelling headphones or the sham control.

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

6 Years to 17 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in CANTAB ADHD Battery - Motor Control Task	Baseline, experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1)	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
Change in CANTAB ADHD Battery - Spatial Working Memory Task	Baseline, experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1)	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
Change in CANTAB ADHD Battery - Stop Signal Reaction Time Task	Baseline, experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1)	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
Change in CANTAB ADHD Battery - Rapid Visual Processing Task	Baseline, experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1)	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

Secondary

Measure	Time frame	Description
Subjective Reports of Experience	Experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1)	Compare the self-reports of noise cancelling headphones versus sham controls - How much did the headphones help you concentrate; self-reported ratings scale with 1 being not at all and 10 being extremely; higher scores indicate that participants reported better concentration during the session for each condition
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)	Compares change from Baseline in Test of Silent Reading and Comprehension (TOSREC) Index score across groups; higher scores indicate better performance compared to Baseline; This scale measures an individual's ability to answer questions about an age/grade referenced reading passage in a set amount of time; higher scores indicate better performance compared to Baseline; Index scores are norm-referenced and can be interpreted similar to standard scores with a mean of 100 and a standard deviation of 15. Scores reported here are changes for an individual and can theoretically range from -50 to +50. A higher score indicates better performance in that condition compared to Baseline - ie., better reading comprehension ability
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)	Compare change from Baseline scores on academic productivity measures (math) - Math Fluency and Calculation Tests (MFACTS) Calculation age standard score; This scale measures an individual's ability to complete age/grade referenced math problems in a set amount of time; higher scores indicate better performance compared to Baseline; standard scores are norm-referenced and have a mean of 100 and a standard deviation of 15. Scores reported here are changes for an individual and can theoretically range from -50 to +50. A higher score indicates better performance in that condition compared to Baseline - ie., better mathematical calculation ability

Countries

United States

Participant flow

Pre-assignment details

5 participants were consented to the study, but failed to meet all inclusion/exclusion criteria

Participants by arm

Arm	Count
Noise Cancelling Headphone First, Then Sham Control Headphone 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. Use of Noise Cancelling Headphones: 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.	17
Sham Control Headphone First, Then Noise Cancelling Headphone 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. Use of Noise Cancelling Headphones: 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.	14
Total	31

Baseline characteristics

Characteristic	Noise Cancelling Headphone First, Then Sham Control Headphone	Total	Sham Control Headphone First, Then Noise Cancelling Headphone
Age, Continuous	9.73 years STANDARD_DEVIATION 2.3	9.63 years STANDARD_DEVIATION 2.15	9.52 years STANDARD_DEVIATION 2.02
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants	2 Participants	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants	29 Participants	13 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) More than one race	1 Participants	3 Participants	2 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	15 Participants	26 Participants	11 Participants
Region of Enrollment United States	17 Participants	31 Participants	14 Participants
Sex: Female, Male Female	6 Participants	10 Participants	4 Participants
Sex: Female, Male Male	11 Participants	21 Participants	10 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 31	0 / 31
other Total, other adverse events	0 / 31	0 / 31
serious Total, serious adverse events	0 / 31	0 / 31

Outcome results

Primary

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