ADHDNCT03216512
Effects of Noise Cancelling Headphones on Neurocognitive and Academic Outcomes in ADHD
A study testing Use of Noise Cancelling Headphones in people with ADHD, run by Duke University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD
- What is being tested?
- Use of Noise Cancelling Headphones
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2018to 31 Jan 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Child and Family Study Center
Durham, North Carolina, 27705
About this study
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)
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.
Read the 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.
- Conditions
- ADHD
- Being tested
- Use of Noise Cancelling Headphones
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Noise Cancelling HeadphonesOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Use of Noise Cancelling Headphones |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
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
Measured: Baseline, experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1)
Subjective Reports of Experience
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
Measured: 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
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
Measured: Baseline, experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study start21 Sep 2018
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Proof-of-concept, randomized, within-subject cross-over design.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Bose Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03216512
- Sponsor's protocol ID
- Pro00084739
- Status last verified
- Jan 2020
- First submitted
- 6 Jul 2017
- Last updated
- 18 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03216512
- Acronym / sponsor ID
- Pro00084739
- Conditions
- ADHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Bose Corporation
- Study start
- 21 Sep 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 13 Jul 2017 (actual)
- Results
- Posted 18 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Proof-of-concept, randomized, within-subject cross-over design.
| Arm | Type | Receives |
|---|---|---|
| Noise cancelling headphone first, then sham control headphone | Experimental | Other: Use of Noise Cancelling HeadphonesThis 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. |
| Sham control headphone first, then noise cancelling headphone | Experimental | Other: Use of Noise Cancelling HeadphonesThis 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. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of Noise Cancelling HeadphonesDuring 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. | Other | Noise cancelling headphone first, then sham control headphone, Sham control headphone first, then noise cancelling headphone |
Primary outcome
Change in CANTAB ADHD Battery - Motor Control Task
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
3 secondary outcomes
Change in Academic Productivity Measures -Math
Time frame: Baseline, experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1)
Subjective Reports of Experience
Time frame: 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
Time frame: Baseline, experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of Noise Cancelling Headphones in people with ADHD, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CANTAB ADHD Battery - Motor Control Task (time frame: Baseline, experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.