Trial Outcomes & Findings for Effects of Noise Cancelling Headphones on Neurocognitive and Academic Outcomes in ADHD (NCT NCT03216512)
NCT ID: NCT03216512
Last Updated: 2020-01-18
Results Overview
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
COMPLETED
NA
36 participants
Baseline, experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1)
2020-01-18
Participant Flow
5 participants were consented to the study, but failed to meet all inclusion/exclusion criteria
Participant milestones
| Measure |
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.
|
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.
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|---|---|---|
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Overall Study
STARTED
|
17
|
14
|
|
Overall Study
COMPLETED
|
17
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Noise Cancelling Headphones on Neurocognitive and Academic Outcomes in ADHD
Baseline characteristics by cohort
| Measure |
Noise Cancelling Headphone First, Then Sham Control Headphone
n=17 Participants
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.
|
Sham Control Headphone First, Then Noise Cancelling Headphone
n=14 Participants
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.
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Total
n=31 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
9.73 years
STANDARD_DEVIATION 2.30 • n=5 Participants
|
9.52 years
STANDARD_DEVIATION 2.02 • n=7 Participants
|
9.63 years
STANDARD_DEVIATION 2.15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Change From Baseline for NC Condition
n=31 Participants
This is the mean change from Baseline for the NC condition across both arms (NC-Sham and Sham-NC)
|
Change From Baseline for Sham Condition
n=31 Participants
This is the mean change from Baseline for the NC condition across both arms (NC-Sham; Sham-NC)
|
|---|---|---|
|
Change in CANTAB ADHD Battery - Motor Control Task
|
-0.033 reaction time (ms)
Standard Deviation 0.183
|
-0.067 reaction time (ms)
Standard Deviation 0.254
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Change From Baseline for NC Condition
n=31 Participants
This is the mean change from Baseline for the NC condition across both arms (NC-Sham and Sham-NC)
|
Change From Baseline for Sham Condition
n=31 Participants
This is the mean change from Baseline for the NC condition across both arms (NC-Sham; Sham-NC)
|
|---|---|---|
|
Change in CANTAB ADHD Battery - Spatial Working Memory Task
|
-3.28 errors
Standard Deviation 7.66
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-3.48 errors
Standard Deviation 9.26
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Change From Baseline for NC Condition
n=31 Participants
This is the mean change from Baseline for the NC condition across both arms (NC-Sham and Sham-NC)
|
Change From Baseline for Sham Condition
n=31 Participants
This is the mean change from Baseline for the NC condition across both arms (NC-Sham; Sham-NC)
|
|---|---|---|
|
Change in CANTAB ADHD Battery - Stop Signal Reaction Time Task
|
117.56 reaction time (ms)
Standard Deviation 95.28
|
78.41 reaction time (ms)
Standard Deviation 26.99
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Change From Baseline for NC Condition
n=31 Participants
This is the mean change from Baseline for the NC condition across both arms (NC-Sham and Sham-NC)
|
Change From Baseline for Sham Condition
n=31 Participants
This is the mean change from Baseline for the NC condition across both arms (NC-Sham; Sham-NC)
|
|---|---|---|
|
Change in CANTAB ADHD Battery - Rapid Visual Processing Task
|
-0.013 correct hits
Standard Deviation 0.079
|
0.001 correct hits
Standard Deviation 0.081
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Change From Baseline for NC Condition
n=31 Participants
This is the mean change from Baseline for the NC condition across both arms (NC-Sham and Sham-NC)
|
Change From Baseline for Sham Condition
n=31 Participants
This is the mean change from Baseline for the NC condition across both arms (NC-Sham; Sham-NC)
|
|---|---|---|
|
Change in Academic Productivity Measures -Math
|
3.77 score on a scale
Standard Deviation 8.5
|
0.87 score on a scale
Standard Deviation 7.02
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Change From Baseline for NC Condition
n=31 Participants
This is the mean change from Baseline for the NC condition across both arms (NC-Sham and Sham-NC)
|
Change From Baseline for Sham Condition
n=31 Participants
This is the mean change from Baseline for the NC condition across both arms (NC-Sham; Sham-NC)
|
|---|---|---|
|
Subjective Reports of Experience
|
6.53 score on a scale
Standard Deviation 2.98
|
6.93 score on a scale
Standard Deviation 2.86
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Change From Baseline for NC Condition
n=31 Participants
This is the mean change from Baseline for the NC condition across both arms (NC-Sham and Sham-NC)
|
Change From Baseline for Sham Condition
n=31 Participants
This is the mean change from Baseline for the NC condition across both arms (NC-Sham; Sham-NC)
|
|---|---|---|
|
Change in Academic Productivity Measures -Reading Comprehension
|
0.33 Index or Standard Score
Standard Deviation 9.68
|
-2.27 Index or Standard Score
Standard Deviation 9.74
|
Adverse Events
Noise Cancelling Headphones
Sham Control Headphones
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place