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| Name | Class |
|---|---|
| Bose Corporation | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Child and Family Study Center | Durham | North Carolina | 27705 | United States |
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5 participants were consented to the study, but failed to meet all inclusion/exclusion criteria
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | reaction time (ms) | Baseline, experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1) |
|
Adverse events were collected from the time of Screening/Enrollment until the last experimental session, which constituted the end of the study, which was on average 4 weeks from the time of Screening
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Noise Cancelling Headphones | This arm is during sessions when participants received noise cancelling headphones |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Scott Kollins | Duke University | 919-681-0014 | scott.kollins@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 18, 2019 | Dec 9, 2019 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 22, 2016 | Dec 9, 2019 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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Proof-of-concept, randomized, within-subject cross-over design.
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The participant won't know whether they are receiving the noise cancelling headphones or the sham control.
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| Baseline, experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1) |
| 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 | 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 | Baseline, experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1) |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 |
| Change From Baseline for Sham Condition |
This is the mean change from Baseline for the NC condition across both arms (NC-Sham; Sham-NC) |
|
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| Secondary | 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 | Posted | Mean | Standard Deviation | score on a scale | Baseline, experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1) |
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| Secondary | 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 | Posted | Mean | Standard Deviation | score on a scale | Experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1) |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | Index or Standard Score | Baseline, experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1) |
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| Primary | 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 | Posted | Mean | Standard Deviation | errors | Baseline, experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1) |
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|
| Primary | 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 | Posted | Mean | Standard Deviation | reaction time (ms) | Baseline, experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1) |
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|
| Primary | 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 | Posted | Mean | Standard Deviation | correct hits | Baseline, experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1) |
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| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Sham Control Headphones | This arm is during sessions when participants received sham control headphones | 0 | 31 | 0 | 31 | 0 | 31 |
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