Trial Outcomes & Findings for Speech Recognition Training in Children With Hearing Loss (NCT NCT04041440)
NCT ID: NCT04041440
Last Updated: 2021-11-10
Results Overview
The measure is percent of 50 common words correctly identified. Words were presented through the application and responses were recorded and scored by the audiologist administering the test.
COMPLETED
PHASE1
34 participants
Before and after the four week training period
2021-11-10
Participant Flow
Participant milestones
| Measure |
Focus Groups
Two groups of children participated in focus groups (N=7 and N=5). Results of subjective questions and focused conversations from the focus groups were used to update and modify the clEAR games to make them more fun and engaging.
|
Auditory Training Group
One group of children participated in auditory training (N=20 completed the protocol, 22 were consented). Results of objective pre- and post-training assessments from the training group were compared to evaluate the effectiveness of the games.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
22
|
|
Overall Study
COMPLETED
|
12
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Focus Groups
Two groups of children participated in focus groups (N=7 and N=5). Results of subjective questions and focused conversations from the focus groups were used to update and modify the clEAR games to make them more fun and engaging.
|
Auditory Training Group
One group of children participated in auditory training (N=20 completed the protocol, 22 were consented). Results of objective pre- and post-training assessments from the training group were compared to evaluate the effectiveness of the games.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Speech Recognition Training in Children With Hearing Loss
Baseline characteristics by cohort
| Measure |
Auditory Training
n=22 Participants
Pre- and post assessments of auditory training intervention
clEAR auditory training: Children play auditory brain training computer gamesFocus
|
Focus Group
n=12 Participants
Two focus groups
Focus groups to collect feedback on current version of games
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
10.6 years
STANDARD_DEVIATION 1.3 • n=5 Participants
|
7.28 years
STANDARD_DEVIATION 1.37 • n=7 Participants
|
9.45 years
STANDARD_DEVIATION 2.04 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
12 participants
n=7 Participants
|
34 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Before and after the four week training periodPopulation: Data are for children with hearing loss who participated in the auditory training part of the study. One participant in the auditory training group was unable to complete the assessments before and after the training because their speech perception ability was below the level of the assessment material. They were allowed to continue the training part of the study to see if they could still be helped by the training. Outcome measures were not collected from the Focus group.
The measure is percent of 50 common words correctly identified. Words were presented through the application and responses were recorded and scored by the audiologist administering the test.
Outcome measures
| Measure |
Auditory Training Group
n=19 Participants
Children playing auditory brain training computer games
|
|---|---|
|
Percentage of Words Identified Before and After Training
Pre-Training Scores
|
49.7 percentage of words presented
Standard Deviation 13.2
|
|
Percentage of Words Identified Before and After Training
Post-Training Scores
|
55.7 percentage of words presented
Standard Deviation 17.6
|
SECONDARY outcome
Timeframe: over course of 4 weeksPopulation: Data were not collected as the protocol was revised to include only testing that could be conducted remotely. This type of cognitive task requires monitored testing procedures.
How quickly, in milliseconds, a word can be discriminated from a competitor
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: over course of 4 weeksPopulation: Data were not collected as the protocol was revised to include only testing that could be conducted remotely. This type of cognitive task requires monitored testing procedures.
Number of words remembered from a list of words presented sequentially
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured once, after the four week training periodPopulation: Data are for children with hearing loss who participated in the auditory training part of the study. Outcome measures were not collected from the Focus Group.
clEAR Questionnaire is given to provide researchers feedback and suggestions about the clEAR games from the child's perspective. The questionnaire used 7-point Likert scales, yes-no questions, open ended questions. Average scores across all of the Likert scale questions are reported here because they are quantifiable. Here are the questions analyzed. 1. How much did you like the home training program? 2. Do you think playing the games improved your speech discrimination abilities? (how well you understand speech) 3. Do you think playing the games improved your confidence in conversation? 4. Did you enjoy playing the games in your home? 5. How likely would you be to tell your friends who have hearing loss about this program? Participants were asked to respond to each item using this scale: (very little) 1 2 3 4 5 6 7 (very much)
Outcome measures
| Measure |
Auditory Training Group
n=20 Participants
Children playing auditory brain training computer games
|
|---|---|
|
Subjective Assessment of clEAR Games on a 7-Point Scale
|
5.25 Units on a 7-point scale
Standard Deviation 1.41
|
Adverse Events
Focus Groups
Auditory Training Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Chief Operating Officer
Customized Learning Exercises for Aural Rehabilitation
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place