Trial Outcomes & Findings for Use of Amplification in Children With Unilateral Hearing Loss (NCT NCT02269124)
NCT ID: NCT02269124
Last Updated: 2021-08-11
Results Overview
The HEAR-QL consists of 28 items that measure the perceived effect of hearing loss on quality of life. It is adjusted to a scale of 0-100, with lower scores indicating a worse disease-specific quality of life and higher scores signifying a better disease-specific quality of life. The HEAER-QL-26 was one of three surveys used to evaluate the study's primary endpoint: subject-reported quality of life.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
37 participants
Primary outcome timeframe
6 months
Results posted on
2021-08-11
Participant Flow
A total of 442 children were assessed for eligibility based on presence of mild to moderately-severe UHL and \> 80% word recognition scores. Of these, 325 did not meet eligibility criteria and 80 declined to participate. Thirty-seven children were enrolled from Massachusetts Eye and Ear (n=25), Boston Children's Hospital (n=5), and Cleveland Clinic (n=7) between 2014 and 2019. Thirty-four children completed study interventions. There was no washout period between arms.
Participant milestones
| Measure |
Conventional Measures Only First; Then Conventional Measures + Hearing Aid
This group was randomized to complete the 3-month "Conventional Measures Only" arm first, followed immediately by the 3-month "Conventional Measures + Hearing Aid" arm. There was no washout period between arms.
|
Conventional Measures + Hearing Aid First; Then Conventional Measures Only
This group was randomized to complete the 3-month "Conventional Measures + Hearing Aid" arm first, followed immediately by the 3-month "Conventional Measures Only" arm. There was no washout period between arms.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
16
|
|
Overall Study
Completed Survey Round 1 (Arm 1, 0 Weeks)
|
20
|
14
|
|
Overall Study
Completed Survey Round 2 (Arm 1, 6 Weeks)
|
17
|
13
|
|
Overall Study
Completed Survey Round 3 (Arm 1, 12 Weeks)
|
17
|
11
|
|
Overall Study
Completed Survey Round 4 (Arm 2, 12 Weeks)
|
11
|
8
|
|
Overall Study
Completed Survey Round 5 (Arm 2, 18 Weeks)
|
16
|
10
|
|
Overall Study
Completed Survey Round 6 (Arm 2, 24 Weeks)
|
14
|
10
|
|
Overall Study
COMPLETED
|
20
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Conventional Measures Only First; Then Conventional Measures + Hearing Aid
This group was randomized to complete the 3-month "Conventional Measures Only" arm first, followed immediately by the 3-month "Conventional Measures + Hearing Aid" arm. There was no washout period between arms.
|
Conventional Measures + Hearing Aid First; Then Conventional Measures Only
This group was randomized to complete the 3-month "Conventional Measures + Hearing Aid" arm first, followed immediately by the 3-month "Conventional Measures Only" arm. There was no washout period between arms.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Use of Amplification in Children With Unilateral Hearing Loss
Baseline characteristics by cohort
| Measure |
Conventional Measures Only First, Then Conventional Methods + Hearing Aid
n=20 Participants
Of the participants who completed the study, twenty (20) were assigned to complete the 3-month "Conventional Measures Only" arm first, during which only FM system and preferential seating were used. After this first 3-month arm, these participants then immediately proceeded to complete the second 3-month "Conventional Measures + Hearing Aid" arm, during which conventional measures and a hearing aid was used.
|
Conventional Measures + Hearing Aid First, Then Conventional Methods Only
n=14 Participants
Of the participants who completed the study, fourteen (14) were assigned to complete the 3-month "Conventional Measures + Hearing Aid" arm first, during which an FM system, preferential seating, and a hearing aid were all used. After this first 3-month arm, these participants then immediately proceeded to complete the second 3-month "Conventional Measures Only" arm, during which only FM system and preferential seating were used.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
20 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
7.9 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
8.1 years
STANDARD_DEVIATION 1.6 • n=7 Participants
|
8.0 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
18 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other/Unknown
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Hearing loss severity
Mild-moderate (20-60 dB PTA)
|
17 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Hearing loss severity
Moderate-severe (60-75 dB PTA)
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Hearing loss type
Conductive
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Hearing loss type
Sensorineural
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Hearing loss type
Mixed
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Hearing loss progression
Stable
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Hearing loss progression
Fluctuating
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Hearing loss progression
Progressive
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Hearing loss etiology
Congenital
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Hearing loss etiology
Acquired
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Hearing loss etiology
Unknown
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
FM system use prior to trial entry
Yes
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
FM system use prior to trial entry
No
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
FM system use prior to trial entry
Unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
State and Hospital of Enrollment
Massachusetts (Massachusetts Eye and Ear)
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
State and Hospital of Enrollment
Massachusetts (Boston Children's Hospital)
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
State and Hospital of Enrollment
Massachusetts Total
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
State and Hospital of Enrollment
Ohio (Cleveland Clinic)
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThe HEAR-QL consists of 28 items that measure the perceived effect of hearing loss on quality of life. It is adjusted to a scale of 0-100, with lower scores indicating a worse disease-specific quality of life and higher scores signifying a better disease-specific quality of life. The HEAER-QL-26 was one of three surveys used to evaluate the study's primary endpoint: subject-reported quality of life.
Outcome measures
| Measure |
Conventional Methods Only First, Then Conventional Methods + Hearing Aid
n=20 Participants
Subjects randomized into the "conventional methods arm" began participating in the study using only conventional methods (FM system and preferential seating in school). Subjects used conventional methods only for 3 months, followed by 3 months using all conventional methods plus a hearing aid. Presented here are averages and standard deviations of survey scores completed by participants randomized into this group at each of the 6 time points, with rounds 1-3 representing conventional methods only and rounds 4-6 representing conventional methods with a hearing aid.
|
Conventional Methods + Hearing Aid First, Then Conventional Methods Only
n=14 Participants
Subjects randomized into the "conventional methods + hearing aid arm" began participating in the study using all conventional methods (FM system and preferential seating in school) in addition to a hearing aid. Subjects used a hearing aid along with all conventional methods for 3 months, followed by 3 months using conventional methods only. Presented here are averages and standard deviations of survey scores completed by participants randomized into this group at each of the 6 time points, with rounds 1-3 representing conventional methods with a hearing aid and rounds 4-6 representing conventional methods only.
|
|---|---|---|
|
HEAR-QL 26 Questionnaire
Survey Round 4 (Arm 2, 12 Weeks)
|
77.78 score on a scale
Standard Deviation 26.06
|
76.31 score on a scale
Standard Deviation 22.86
|
|
HEAR-QL 26 Questionnaire
Survey Round 1 (Arm 1, 0 Weeks)
|
69.61 score on a scale
Standard Deviation 15.06
|
74.05 score on a scale
Standard Deviation 15.14
|
|
HEAR-QL 26 Questionnaire
Survey Round 2 (Arm 1, 6 Weeks)
|
71.04 score on a scale
Standard Deviation 18.29
|
80.21 score on a scale
Standard Deviation 16.22
|
|
HEAR-QL 26 Questionnaire
Survey Round 3 (Arm 1, 12 Weeks)
|
74.31 score on a scale
Standard Deviation 20.43
|
87.15 score on a scale
Standard Deviation 10.48
|
|
HEAR-QL 26 Questionnaire
Survey Round 5 (Arm 2, 18 Weeks)
|
79.13 score on a scale
Standard Deviation 21.75
|
73.32 score on a scale
Standard Deviation 24.32
|
|
HEAR-QL 26 Questionnaire
Survey Round 6 (Arm 2, 24 Weeks)
|
80.42 score on a scale
Standard Deviation 23.14
|
75.17 score on a scale
Standard Deviation 23.03
|
PRIMARY outcome
Timeframe: 6 monthsThe CHILD (child) questionnaire consists of 15 questions that describe situations where hearing difficulty may occur when the child is with his/her family. The answers are measured on a scale of 1-8, with 1 indicating poor ability to hear, and 8 indicating complete understanding. The total scores across all questions were standardized on a scale of 0 to 100, with lower scores indicating a worse disease-specific quality of life and higher scores signifying a better disease-specific quality of life. Two versions, the CHILD (child) and the CHILD (parent) are phrased to apply to the child and the parent respectively. The CHILD (child) was one of three surveys used to evaluate the study's primary endpoint: subject-reported quality of life.
Outcome measures
| Measure |
Conventional Methods Only First, Then Conventional Methods + Hearing Aid
n=20 Participants
Subjects randomized into the "conventional methods arm" began participating in the study using only conventional methods (FM system and preferential seating in school). Subjects used conventional methods only for 3 months, followed by 3 months using all conventional methods plus a hearing aid. Presented here are averages and standard deviations of survey scores completed by participants randomized into this group at each of the 6 time points, with rounds 1-3 representing conventional methods only and rounds 4-6 representing conventional methods with a hearing aid.
|
Conventional Methods + Hearing Aid First, Then Conventional Methods Only
n=14 Participants
Subjects randomized into the "conventional methods + hearing aid arm" began participating in the study using all conventional methods (FM system and preferential seating in school) in addition to a hearing aid. Subjects used a hearing aid along with all conventional methods for 3 months, followed by 3 months using conventional methods only. Presented here are averages and standard deviations of survey scores completed by participants randomized into this group at each of the 6 time points, with rounds 1-3 representing conventional methods with a hearing aid and rounds 4-6 representing conventional methods only.
|
|---|---|---|
|
CHILD (Child) Questionnaires
Survey Round 4 (Arm 2, 12 Weeks)
|
90.36 score on a scale
Standard Deviation 10.55
|
67.16 score on a scale
Standard Deviation 20.83
|
|
CHILD (Child) Questionnaires
Survey Round 5 (Arm 2, 18 Weeks)
|
81.76 score on a scale
Standard Deviation 18.69
|
65.42 score on a scale
Standard Deviation 26.41
|
|
CHILD (Child) Questionnaires
Survey Round 6 (Arm 2, 24 Weeks)
|
88.61 score on a scale
Standard Deviation 11.83
|
70.43 score on a scale
Standard Deviation 23.66
|
|
CHILD (Child) Questionnaires
Survey Round 1 (Arm 1, 0 Weeks)
|
69.21 score on a scale
Standard Deviation 21.55
|
72.83 score on a scale
Standard Deviation 16.51
|
|
CHILD (Child) Questionnaires
Survey Round 2 (Arm 1, 6 Weeks)
|
75.23 score on a scale
Standard Deviation 17.28
|
82.83 score on a scale
Standard Deviation 9.64
|
|
CHILD (Child) Questionnaires
Survey Round 3 (Arm 1, 12 Weeks)
|
77.59 score on a scale
Standard Deviation 13.78
|
80.13 score on a scale
Standard Deviation 14.18
|
PRIMARY outcome
Timeframe: 6 monthsThe LIFE-R Student questionnaire consists of 15 questions that describe situations where hearing difficulty may occur in school. The answers are measured on a scale of 1-5, with 1 indicating situations in which hearing is always difficult and 5 indicating situations where hearing is always easy. The scores are then added standardized from 0 to 100, with lower scores representing a higher frequency of hearing difficulties in the classroom and higher score representing a lower frequency of hearing difficulties. Two versions, the LIFE-R student and the LIFE-R teacher are phrased to apply to the student and the teacher respectively. The LIFE-R Student questionnaire is one of three surveys used to evaluate the primary endpoint: subject-reported quality of life.
Outcome measures
| Measure |
Conventional Methods Only First, Then Conventional Methods + Hearing Aid
n=20 Participants
Subjects randomized into the "conventional methods arm" began participating in the study using only conventional methods (FM system and preferential seating in school). Subjects used conventional methods only for 3 months, followed by 3 months using all conventional methods plus a hearing aid. Presented here are averages and standard deviations of survey scores completed by participants randomized into this group at each of the 6 time points, with rounds 1-3 representing conventional methods only and rounds 4-6 representing conventional methods with a hearing aid.
|
Conventional Methods + Hearing Aid First, Then Conventional Methods Only
n=14 Participants
Subjects randomized into the "conventional methods + hearing aid arm" began participating in the study using all conventional methods (FM system and preferential seating in school) in addition to a hearing aid. Subjects used a hearing aid along with all conventional methods for 3 months, followed by 3 months using conventional methods only. Presented here are averages and standard deviations of survey scores completed by participants randomized into this group at each of the 6 time points, with rounds 1-3 representing conventional methods with a hearing aid and rounds 4-6 representing conventional methods only.
|
|---|---|---|
|
LIFE-R Student Questionnaires
Survey Round 1 (Arm 1, 0 Weeks)
|
58.83 score on a scale
Standard Deviation 18.86
|
67.05 score on a scale
Standard Deviation 15.29
|
|
LIFE-R Student Questionnaires
Survey Round 2 (Arm 1, 6 Weeks)
|
62.81 score on a scale
Standard Deviation 19.78
|
77.05 score on a scale
Standard Deviation 13.25
|
|
LIFE-R Student Questionnaires
Survey Round 4 (Arm 2, 12 Weeks)
|
78.76 score on a scale
Standard Deviation 15.15
|
63.13 score on a scale
Standard Deviation 23.68
|
|
LIFE-R Student Questionnaires
Survey Round 3 (Arm 1, 12 Weeks)
|
64.78 score on a scale
Standard Deviation 17.90
|
80.37 score on a scale
Standard Deviation 15.18
|
|
LIFE-R Student Questionnaires
Survey Round 5 (Arm 2, 18 Weeks)
|
75.94 score on a scale
Standard Deviation 18.79
|
62.22 score on a scale
Standard Deviation 24.09
|
|
LIFE-R Student Questionnaires
Survey Round 6 (Arm 2, 24 Weeks)
|
80.15 score on a scale
Standard Deviation 16.07
|
63.89 score on a scale
Standard Deviation 25.00
|
SECONDARY outcome
Timeframe: 6 monthsThe LIFE-R Teacher questionnaire consists of 14 questions that evaluate the student's academic performance, including ability to focus, follow directions, and understand scholastic material when verbally administered. The answers are measured on a scale of 1-5, with 1 indicating a point of constant challenge for the student and 5 indicating no challenge. The scores are then added and standardized from 0 to 100, with lower scores representing a higher frequency of hearing difficulties in the classroom and higher score representing a lower frequency of hearing difficulties. Two versions, the LIFE-R student and the LIFE-R teacher are phrased to apply to the student and the teacher respectively. The LIFE-R Teacher questionnaire was used to evaluate one of the secondary endpoints: classroom performance.
Outcome measures
| Measure |
Conventional Methods Only First, Then Conventional Methods + Hearing Aid
n=20 Participants
Subjects randomized into the "conventional methods arm" began participating in the study using only conventional methods (FM system and preferential seating in school). Subjects used conventional methods only for 3 months, followed by 3 months using all conventional methods plus a hearing aid. Presented here are averages and standard deviations of survey scores completed by participants randomized into this group at each of the 6 time points, with rounds 1-3 representing conventional methods only and rounds 4-6 representing conventional methods with a hearing aid.
|
Conventional Methods + Hearing Aid First, Then Conventional Methods Only
n=14 Participants
Subjects randomized into the "conventional methods + hearing aid arm" began participating in the study using all conventional methods (FM system and preferential seating in school) in addition to a hearing aid. Subjects used a hearing aid along with all conventional methods for 3 months, followed by 3 months using conventional methods only. Presented here are averages and standard deviations of survey scores completed by participants randomized into this group at each of the 6 time points, with rounds 1-3 representing conventional methods with a hearing aid and rounds 4-6 representing conventional methods only.
|
|---|---|---|
|
LIFE-R Teacher
Survey Round 3 (Arm 1, 12 Weeks)
|
74.26 score on a scale
Standard Deviation 17.63
|
89.77 score on a scale
Standard Deviation 9.74
|
|
LIFE-R Teacher
Survey Round 4 (Arm 2, 12 Weeks)
|
75.74 score on a scale
Standard Deviation 19.47
|
79.57 score on a scale
Standard Deviation 15.54
|
|
LIFE-R Teacher
Survey Round 6 (Arm 2, 24 Weeks)
|
83.94 score on a scale
Standard Deviation 16.08
|
83.27 score on a scale
Standard Deviation 16.73
|
|
LIFE-R Teacher
Survey Round 1 (Arm 1, 0 Weeks)
|
68.69 score on a scale
Standard Deviation 20.80
|
83.55 score on a scale
Standard Deviation 11.00
|
|
LIFE-R Teacher
Survey Round 2 (Arm 1, 6 Weeks)
|
73.66 score on a scale
Standard Deviation 19.55
|
90.61 score on a scale
Standard Deviation 6.82
|
|
LIFE-R Teacher
Survey Round 5 (Arm 2, 18 Weeks)
|
83.31 score on a scale
Standard Deviation 17.81
|
78.08 score on a scale
Standard Deviation 19.96
|
SECONDARY outcome
Timeframe: 6 monthsThe CHILD (parent) questionnaire consists of 15 questions that describe situations where hearing difficulty may occur when the child is with his/her family. The answers are measured on a scale of 1-8, with 1 indicating poor ability to hear, and 8 indicating complete understanding. The total scores across all questions were standardized on a scale of 0 to 100, with lower scores indicating a worse disease-specific quality of life and higher scores signifying a better disease-specific quality of life. Two versions, the CHILD (child) and the CHILD (parent) are phrased to apply to the child and the parent respectively. The CHILD (parent) survey was used to evaluate one of the study's secondary endpoints: impact of hearing aid with respect to parental perception.
Outcome measures
| Measure |
Conventional Methods Only First, Then Conventional Methods + Hearing Aid
n=20 Participants
Subjects randomized into the "conventional methods arm" began participating in the study using only conventional methods (FM system and preferential seating in school). Subjects used conventional methods only for 3 months, followed by 3 months using all conventional methods plus a hearing aid. Presented here are averages and standard deviations of survey scores completed by participants randomized into this group at each of the 6 time points, with rounds 1-3 representing conventional methods only and rounds 4-6 representing conventional methods with a hearing aid.
|
Conventional Methods + Hearing Aid First, Then Conventional Methods Only
n=14 Participants
Subjects randomized into the "conventional methods + hearing aid arm" began participating in the study using all conventional methods (FM system and preferential seating in school) in addition to a hearing aid. Subjects used a hearing aid along with all conventional methods for 3 months, followed by 3 months using conventional methods only. Presented here are averages and standard deviations of survey scores completed by participants randomized into this group at each of the 6 time points, with rounds 1-3 representing conventional methods with a hearing aid and rounds 4-6 representing conventional methods only.
|
|---|---|---|
|
CHILD (Parent) Questionnaire
Survey Round 1 (Arm 1, 0 Weeks)
|
68.52 score on a scale
Standard Deviation 19.57
|
73.40 score on a scale
Standard Deviation 12.96
|
|
CHILD (Parent) Questionnaire
Survey Round 2 (Arm 1, 6 Weeks)
|
67.24 score on a scale
Standard Deviation 13.52
|
81.81 score on a scale
Standard Deviation 10.29
|
|
CHILD (Parent) Questionnaire
Survey Round 3 (Arm 1, 12 Weeks)
|
72.77 score on a scale
Standard Deviation 16.70
|
81.73 score on a scale
Standard Deviation 12.79
|
|
CHILD (Parent) Questionnaire
Survey Round 4 (Arm 2, 12 Weeks)
|
91.24 score on a scale
Standard Deviation 5.78
|
64.19 score on a scale
Standard Deviation 19.93
|
|
CHILD (Parent) Questionnaire
Survey Round 5 (Arm 2, 18 Weeks)
|
85.93 score on a scale
Standard Deviation 15.31
|
68.13 score on a scale
Standard Deviation 26.41
|
|
CHILD (Parent) Questionnaire
Survey Round 6 (Arm 2, 24 Weeks)
|
84.27 score on a scale
Standard Deviation 14.47
|
63.10 score on a scale
Standard Deviation 23.81
|
Adverse Events
Conventional Measures Only First; Then Conventional Measures + Hearing Aid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Conventional Measures + Hearing Aid First; Then Conventional Measures Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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