Trial Outcomes & Findings for Hearing Aid and Individuals With Cognitive Disorders (NCT NCT04049643)
NCT ID: NCT04049643
Last Updated: 2025-04-17
Results Overview
The IOI-HA is a questionnaire designed to assess the benefits of hearing aids from the user's perspective. The score ranges from 1 (less benefit) to 5 (more benefit).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
17 participants
Primary outcome timeframe
6 weeks after the first day participants started using hearing aids.
Results posted on
2025-04-17
Participant Flow
Participant milestones
| Measure |
Audiologist-Based
In this group, the audiologist-based fitting will be used to provide hearing aids.
Audiologist-based fitting: Hearing aids will be fitted by audiologists using established procedures.
|
Service-Only
In this group, hearing aids that have minimum amplification will be fitted by audiologists.
Service-only Fitting: This intervention group is designed to explore the contribution of amplification devices in hearing aid intervention, which consists of devices and services. In this intervention group, audiological services plus hearing aids that provide minimum amplification will be provided. Specifically, patient participants in this group will receive audiological services (e.g., counselling and education), except that the hearing aids will be set to provide no amplification other than what is needed to overcome any sounds that are dampened by the earpieces.
|
Device-Only
In this group, hearing aids will be provided with minimum services from audiologists.
Device-only fitting: This intervention group is designed to explore the contribution of amplification devices in hearing aid intervention, which consists of devices and services. The patient participants in this intervention group will have minimum services regarding the pre-fitting, selection, and orientation of the hearing aids. The participants will have a hearing evaluation, including pure-tone audiometry. The audiologist will select the amplification characteristics and non-custom ear piece based on the audiogram. The audiologist will then briefly orient the participant on how to use the hearing aids and counsel on how to optimize their performance.
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
3
|
5
|
|
Overall Study
COMPLETED
|
8
|
2
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
Audiologist-Based
In this group, the audiologist-based fitting will be used to provide hearing aids.
Audiologist-based fitting: Hearing aids will be fitted by audiologists using established procedures.
|
Service-Only
In this group, hearing aids that have minimum amplification will be fitted by audiologists.
Service-only Fitting: This intervention group is designed to explore the contribution of amplification devices in hearing aid intervention, which consists of devices and services. In this intervention group, audiological services plus hearing aids that provide minimum amplification will be provided. Specifically, patient participants in this group will receive audiological services (e.g., counselling and education), except that the hearing aids will be set to provide no amplification other than what is needed to overcome any sounds that are dampened by the earpieces.
|
Device-Only
In this group, hearing aids will be provided with minimum services from audiologists.
Device-only fitting: This intervention group is designed to explore the contribution of amplification devices in hearing aid intervention, which consists of devices and services. The patient participants in this intervention group will have minimum services regarding the pre-fitting, selection, and orientation of the hearing aids. The participants will have a hearing evaluation, including pure-tone audiometry. The audiologist will select the amplification characteristics and non-custom ear piece based on the audiogram. The audiologist will then briefly orient the participant on how to use the hearing aids and counsel on how to optimize their performance.
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
0
|
|
Overall Study
Health concern (unrelated to the intervention of the study)
|
0
|
0
|
1
|
Baseline Characteristics
Hearing Aid and Individuals With Cognitive Disorders
Baseline characteristics by cohort
| Measure |
Audiologist-Based
n=8 Participants
In this group, the audiologist-based fitting will be used to provide hearing aids.
Audiologist-based fitting: Hearing aids will be fitted by audiologists using established procedures.
|
Service-Only
n=2 Participants
In this group, hearing aids that have minimum amplification will be fitted by audiologists.
Service-only Fitting: This intervention group is designed to explore the contribution of amplification devices in hearing aid intervention, which consists of devices and services. In this intervention group, audiological services plus hearing aids that provide minimum amplification will be provided. Specifically, patient participants in this group will receive audiological services (e.g., counselling and education), except that the hearing aids will be set to provide no amplification other than what is needed to overcome any sounds that are dampened by the earpieces.
|
Device-Only
n=4 Participants
In this group, hearing aids will be provided with minimum services from audiologists.
Device-only fitting: This intervention group is designed to explore the contribution of amplification devices in hearing aid intervention, which consists of devices and services. The patient participants in this intervention group will have minimum services regarding the pre-fitting, selection, and orientation of the hearing aids. The participants will have a hearing evaluation, including pure-tone audiometry. The audiologist will select the amplification characteristics and non-custom ear piece based on the audiogram. The audiologist will then briefly orient the participant on how to use the hearing aids and counsel on how to optimize their performance.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
72.4 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
74 years
STANDARD_DEVIATION 1.4 • n=7 Participants
|
60.5 years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
69 years
STANDARD_DEVIATION 11.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Hearing loss (pure-tone average)
|
36.8 dB HL
STANDARD_DEVIATION 5.0 • n=5 Participants
|
22.1 dB HL
STANDARD_DEVIATION 4.1 • n=7 Participants
|
21.9 dB HL
STANDARD_DEVIATION 5.3 • n=5 Participants
|
30.4 dB HL
STANDARD_DEVIATION 8.9 • n=4 Participants
|
PRIMARY outcome
Timeframe: 6 weeks after the first day participants started using hearing aids.The IOI-HA is a questionnaire designed to assess the benefits of hearing aids from the user's perspective. The score ranges from 1 (less benefit) to 5 (more benefit).
Outcome measures
| Measure |
Audiologist-Based
n=8 Participants
In this group, the audiologist-based fitting will be used to provide hearing aids.
Audiologist-based fitting: Hearing aids will be fitted by audiologists using established procedures.
|
Service-Only
n=2 Participants
In this group, hearing aids that have minimum amplification will be fitted by audiologists.
Service-only Fitting: This intervention group is designed to explore the contribution of amplification devices in hearing aid intervention, which consists of devices and services. In this intervention group, audiological services plus hearing aids that provide minimum amplification will be provided. Specifically, patient participants in this group will receive audiological services (e.g., counselling and education), except that the hearing aids will be set to provide no amplification other than what is needed to overcome any sounds that are dampened by the earpieces.
|
Device-Only
n=4 Participants
In this group, hearing aids will be provided with minimum services from audiologists.
Device-only fitting: This intervention group is designed to explore the contribution of amplification devices in hearing aid intervention, which consists of devices and services. The patient participants in this intervention group will have minimum services regarding the pre-fitting, selection, and orientation of the hearing aids. The participants will have a hearing evaluation, including pure-tone audiometry. The audiologist will select the amplification characteristics and non-custom ear piece based on the audiogram. The audiologist will then briefly orient the participant on how to use the hearing aids and counsel on how to optimize their performance.
|
|---|---|---|---|
|
Hearing Aid Benefit as Measured by the International Outcomes Inventory for Hearing Aids (IOI-HA)
|
3.9 score on a scale
Standard Deviation 0.6
|
3.4 score on a scale
Standard Deviation 0.3
|
3.7 score on a scale
Standard Deviation 0.6
|
PRIMARY outcome
Timeframe: Immediately before hearing aid use and 6 weeks after the first day of hearing aid useThe IADL was developed to assess independent living skills, such as feeding, dressing, and food preparation. The score ranges from 0 (low function) to 8 (high function). Participants complete this measure pre-intervention and at 6 weeks post-intervention. The change in scores between pre- and post-intervention are reported, with score changes ranging from +8 (indicating a benefit from hearing aids) to -8 (indicating a detrimental effect of hearing aids).
Outcome measures
| Measure |
Audiologist-Based
n=8 Participants
In this group, the audiologist-based fitting will be used to provide hearing aids.
Audiologist-based fitting: Hearing aids will be fitted by audiologists using established procedures.
|
Service-Only
n=2 Participants
In this group, hearing aids that have minimum amplification will be fitted by audiologists.
Service-only Fitting: This intervention group is designed to explore the contribution of amplification devices in hearing aid intervention, which consists of devices and services. In this intervention group, audiological services plus hearing aids that provide minimum amplification will be provided. Specifically, patient participants in this group will receive audiological services (e.g., counselling and education), except that the hearing aids will be set to provide no amplification other than what is needed to overcome any sounds that are dampened by the earpieces.
|
Device-Only
n=4 Participants
In this group, hearing aids will be provided with minimum services from audiologists.
Device-only fitting: This intervention group is designed to explore the contribution of amplification devices in hearing aid intervention, which consists of devices and services. The patient participants in this intervention group will have minimum services regarding the pre-fitting, selection, and orientation of the hearing aids. The participants will have a hearing evaluation, including pure-tone audiometry. The audiologist will select the amplification characteristics and non-custom ear piece based on the audiogram. The audiologist will then briefly orient the participant on how to use the hearing aids and counsel on how to optimize their performance.
|
|---|---|---|---|
|
Change of Daily Activity as Measured by the Lawton Instrumental Activities of Daily Living Scale (IADL)
|
1 score on a scale
Standard Deviation 5
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Immediately before hearing aid use and 6 weeks after the first day of hearing aid useCaregiver burden will be measured using the ZBI, which is a 22-item questionnaire. The ZBI measures self-reported burden in terms of the degree (from 'never' to 'almost always') to which the caregiver experiences physical, psychological, emotional, social and financial problems as a result of their care-giving role. The score ranges from 0 (little or no burden) to 88 (severe burden). This measure is completed pre-intervention and at 6 weeks post-intervention. The change in scores between pre- and post-intervention are reported, with score changes ranging from -88 (indicating a benefit from hearing aids) to +88 (indicating a detrimental effect of hearing aids).
Outcome measures
| Measure |
Audiologist-Based
n=8 Participants
In this group, the audiologist-based fitting will be used to provide hearing aids.
Audiologist-based fitting: Hearing aids will be fitted by audiologists using established procedures.
|
Service-Only
n=2 Participants
In this group, hearing aids that have minimum amplification will be fitted by audiologists.
Service-only Fitting: This intervention group is designed to explore the contribution of amplification devices in hearing aid intervention, which consists of devices and services. In this intervention group, audiological services plus hearing aids that provide minimum amplification will be provided. Specifically, patient participants in this group will receive audiological services (e.g., counselling and education), except that the hearing aids will be set to provide no amplification other than what is needed to overcome any sounds that are dampened by the earpieces.
|
Device-Only
n=4 Participants
In this group, hearing aids will be provided with minimum services from audiologists.
Device-only fitting: This intervention group is designed to explore the contribution of amplification devices in hearing aid intervention, which consists of devices and services. The patient participants in this intervention group will have minimum services regarding the pre-fitting, selection, and orientation of the hearing aids. The participants will have a hearing evaluation, including pure-tone audiometry. The audiologist will select the amplification characteristics and non-custom ear piece based on the audiogram. The audiologist will then briefly orient the participant on how to use the hearing aids and counsel on how to optimize their performance.
|
|---|---|---|---|
|
Change of Caregiver Burden as Measured by the "Zarit Burden Interview" (ZBI)
|
-2.6 score on a scale
Standard Deviation 5.5
|
-7 score on a scale
Standard Deviation 2.8
|
-1 score on a scale
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: Immediately before hearing aid use and 6 weeks after the first day of hearing aid useThe HHIE and HHIA are questionnaires designed to measure perceived hearing handicap. For subjects order and younger 65 years old, the HHIE and HHIA will be used, respectively. The score ranges from 0 (no handicap) to 100 (more handicap) (i.e., lower scores mean less handicap). Participants will complete this questionnaire pre-intervention and at 6 weeks post-intervention. The change in scores between pre- and post-intervention are reported, with score changes ranging from -100 (indicating a benefit from hearing aids) to +100 (indicating a detrimental effect of hearing aids).
Outcome measures
| Measure |
Audiologist-Based
n=6 Participants
In this group, the audiologist-based fitting will be used to provide hearing aids.
Audiologist-based fitting: Hearing aids will be fitted by audiologists using established procedures.
|
Service-Only
n=2 Participants
In this group, hearing aids that have minimum amplification will be fitted by audiologists.
Service-only Fitting: This intervention group is designed to explore the contribution of amplification devices in hearing aid intervention, which consists of devices and services. In this intervention group, audiological services plus hearing aids that provide minimum amplification will be provided. Specifically, patient participants in this group will receive audiological services (e.g., counselling and education), except that the hearing aids will be set to provide no amplification other than what is needed to overcome any sounds that are dampened by the earpieces.
|
Device-Only
n=4 Participants
In this group, hearing aids will be provided with minimum services from audiologists.
Device-only fitting: This intervention group is designed to explore the contribution of amplification devices in hearing aid intervention, which consists of devices and services. The patient participants in this intervention group will have minimum services regarding the pre-fitting, selection, and orientation of the hearing aids. The participants will have a hearing evaluation, including pure-tone audiometry. The audiologist will select the amplification characteristics and non-custom ear piece based on the audiogram. The audiologist will then briefly orient the participant on how to use the hearing aids and counsel on how to optimize their performance.
|
|---|---|---|---|
|
Change of Hearing Handicap Measured by Hearing Handicap Inventory for the Elderly (HHIE) or Hearing Handicap Inventory for Adults (HHIA)
|
-36 score on a scale
Standard Deviation 20.1
|
-14 score on a scale
Standard Deviation 11.3
|
-17.5 score on a scale
Standard Deviation 21.7
|
SECONDARY outcome
Timeframe: Immediately before hearing aid use and 6 weeks after the first day of hearing aid useThe ADRQL was developed to assess health related quality of life in people with Alzheimer's disease using assessments from family caregivers or professional staff. The score ranges from 0 (worst situation) to 100 (best situation). Participants complete this measure pre-intervention and at 6 weeks post-intervention. The change in scores between pre- and post-intervention are reported, with score changes ranging from +100 (indicating a benefit from hearing aids) to -100 (indicating a detrimental effect of hearing aids).
Outcome measures
| Measure |
Audiologist-Based
n=8 Participants
In this group, the audiologist-based fitting will be used to provide hearing aids.
Audiologist-based fitting: Hearing aids will be fitted by audiologists using established procedures.
|
Service-Only
n=2 Participants
In this group, hearing aids that have minimum amplification will be fitted by audiologists.
Service-only Fitting: This intervention group is designed to explore the contribution of amplification devices in hearing aid intervention, which consists of devices and services. In this intervention group, audiological services plus hearing aids that provide minimum amplification will be provided. Specifically, patient participants in this group will receive audiological services (e.g., counselling and education), except that the hearing aids will be set to provide no amplification other than what is needed to overcome any sounds that are dampened by the earpieces.
|
Device-Only
n=4 Participants
In this group, hearing aids will be provided with minimum services from audiologists.
Device-only fitting: This intervention group is designed to explore the contribution of amplification devices in hearing aid intervention, which consists of devices and services. The patient participants in this intervention group will have minimum services regarding the pre-fitting, selection, and orientation of the hearing aids. The participants will have a hearing evaluation, including pure-tone audiometry. The audiologist will select the amplification characteristics and non-custom ear piece based on the audiogram. The audiologist will then briefly orient the participant on how to use the hearing aids and counsel on how to optimize their performance.
|
|---|---|---|---|
|
Change of Quality of Life as Measured by the Alzheimer's Disease-Related Quality of Life (ADRQL)
|
5.0 score on a scale
Standard Deviation 8.3
|
13.8 score on a scale
Standard Deviation 30
|
1.25 score on a scale
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: Immediately before hearing aid use and 6 weeks after the first day of hearing aid useThe GDS a self-report measure of depression in older adults. The short form of the GDS has 15 items. The score ranges from 0 (no depression) to 15 (more depression) Participants complete this measure pre-intervention and at 6 weeks post-intervention. The change in scores between pre- and post-intervention are reported, with score changes ranging from -15 (indicating a benefit from hearing aids) to +15 (indicating a detrimental effect of hearing aids).
Outcome measures
| Measure |
Audiologist-Based
n=7 Participants
In this group, the audiologist-based fitting will be used to provide hearing aids.
Audiologist-based fitting: Hearing aids will be fitted by audiologists using established procedures.
|
Service-Only
n=2 Participants
In this group, hearing aids that have minimum amplification will be fitted by audiologists.
Service-only Fitting: This intervention group is designed to explore the contribution of amplification devices in hearing aid intervention, which consists of devices and services. In this intervention group, audiological services plus hearing aids that provide minimum amplification will be provided. Specifically, patient participants in this group will receive audiological services (e.g., counselling and education), except that the hearing aids will be set to provide no amplification other than what is needed to overcome any sounds that are dampened by the earpieces.
|
Device-Only
n=3 Participants
In this group, hearing aids will be provided with minimum services from audiologists.
Device-only fitting: This intervention group is designed to explore the contribution of amplification devices in hearing aid intervention, which consists of devices and services. The patient participants in this intervention group will have minimum services regarding the pre-fitting, selection, and orientation of the hearing aids. The participants will have a hearing evaluation, including pure-tone audiometry. The audiologist will select the amplification characteristics and non-custom ear piece based on the audiogram. The audiologist will then briefly orient the participant on how to use the hearing aids and counsel on how to optimize their performance.
|
|---|---|---|---|
|
Change of Depression as Measured Using the Geriatric Depression Scale (GDS)
|
-0.85 score on a scale
Standard Deviation 2.4
|
0.5 score on a scale
Standard Deviation 0.7
|
-0.33 score on a scale
Standard Deviation 0.57
|
Adverse Events
Audiologist-Based
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Service-Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Device-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