Alzheimer Disease 2 Due to Apoe4 Isoform, Mild Cognitive Impairment, Presbycusis, Bilateral
Conditions
Keywords
Presbycusis, Hearing aid, Alzheimer Disease, Mild Cognitive Impairment
Brief summary
This is a pilot study with the aim of evaluating the feasibility of the procedures of a future clinical trial that will help determine the impacts of hearing aid interventions on older patients with Alzheimer's Disease and related dementias (ADRD). In this pilot study individuals with mild or moderate cognitive impairment, as well as their caregivers, will be recruited. Participants will be randomly assigned to three intervention groups: Audiologist-Based Intervention, Service-Only Group, and Device-Only Group. Outcome data will be collected on the how hearing loss and hearing aid impact their lives and caregiver burden 6-week post hearing aid intervention.
Detailed description
A disorder that often affect older adults is age-related hearing loss. It is estimated that about two-thirds of persons aged 70 years or older exhibit hearing problems. Left untreated, age-related hearing loss can affect an individual's ability to communicate and to interact with his/her environment and can contribute to psychological symptoms such depression, anxiety, isolation, paranoia, and possibly dementia. Because (1) the neuropsychiatric symptoms associated with dementia could be exacerbated by poor communication resulting from hearing loss and (2) it has been widely accepted that hearing aids (HAs) are effective in improving communication function and reducing the psychosocial consequences associated with hearing loss for older adults without dementia, it seems reasonable to use HAs to treat the hearing loss of adults with Alzheimer's Disease and related dementias (ADRD). However, it has been argued that because the pathology of ADRD could involve central auditory pathways and nuclei, HAs-the devices that improve audibility at the peripheral level of the auditory system-may not be an effective management for ADRD. To date there is no high-quality evidence to support or negate the benefit of HA intervention on adults with dementia in reducing communication difficulty, dementia-related symptoms, and caregiver burdens. Therefore, the benefit of HA intervention on adults with ADRD remains unknown. Further, the best service model to provide HAs for older adults with ADRD is unknown. On one hand, it is likely that customized HAs fitted by audiologists using best practices could generate optimal outcomes. However, implementing the best-practice audiology services is challenging in this population. On the other hand, recent literature suggests that audiologists could fit low-cost, pre-programmed, non-customized amplification devices to adults with ADRD to reduce the cost of HA intervention, while yielding reasonable outcomes.To date there is no high-quality research rigorously examining the outcome, value, and candidacy of different HA service-delivery models for older adults with ADRD. This is a pilot study with the aim of evaluating the feasibility of the procedures of a future clinical trial that will help determine the impacts of hearing aid interventions on older patients with ADRD. We expect that at least a total of 30 patients will complete the pilot study. The collected data will provide valuable information for us to formulate or revise the hypotheses, conduct power analysis, and finalize the research protocol for the future clinical trial.
Interventions
Hearing aids will be fitted by audiologists using established procedures.
DEVICEService-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.
DEVICEDevice-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.
Sponsors
Vanderbilt University Medical Center
National Institute on Deafness and Other Communication Disorders (NIDCD)
Yu-Hsiang Wu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Montreal Cognitive Assessment (MoCA) score lower than 25 points * Adult-onset mild-to-moderate sensorineural hearing loss
Exclusion criteria
* Non-native English speaker * Prior hearing aid experience
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hearing Aid Benefit as Measured by the International Outcomes Inventory for Hearing Aids (IOI-HA) | 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). |
| Change of Daily Activity as Measured by the Lawton Instrumental Activities of Daily Living Scale (IADL) | Immediately before hearing aid use and 6 weeks after the first day of hearing aid use | The 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). |
| Change of Caregiver Burden as Measured by the Zarit Burden Interview (ZBI) | Immediately before hearing aid use and 6 weeks after the first day of hearing aid use | Caregiver 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Hearing Handicap Measured by Hearing Handicap Inventory for the Elderly (HHIE) or Hearing Handicap Inventory for Adults (HHIA) | Immediately before hearing aid use and 6 weeks after the first day of hearing aid use | The 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). |
| Change of Quality of Life as Measured by the Alzheimer's Disease-Related Quality of Life (ADRQL) | Immediately before hearing aid use and 6 weeks after the first day of hearing aid use | The 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). |
| Change of Depression as Measured Using the Geriatric Depression Scale (GDS) | Immediately before hearing aid use and 6 weeks after the first day of hearing aid use | The 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 8 |
| 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. | 2 |
| 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. | 4 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Health concern (unrelated to the intervention of the study) | 0 | 0 | 1 |
| Overall Study | Lack of Efficacy | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Audiologist-Based | Service-Only | Device-Only | Total |
|---|---|---|---|---|
| Age, Continuous | 72.4 years STANDARD_DEVIATION 8.2 | 74 years STANDARD_DEVIATION 1.4 | 60.5 years STANDARD_DEVIATION 14.7 | 69 years STANDARD_DEVIATION 11.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 2 Participants | 4 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Hearing loss (pure-tone average) | 36.8 dB HL STANDARD_DEVIATION 5 | 22.1 dB HL STANDARD_DEVIATION 4.1 | 21.9 dB HL STANDARD_DEVIATION 5.3 | 30.4 dB HL STANDARD_DEVIATION 8.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 2 Participants | 4 Participants | 14 Participants |
| Region of Enrollment United States | 8 participants | 2 participants | 4 participants | 14 participants |
| Sex: Female, Male Female | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | 6 Participants | 2 Participants | 4 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 2 | 0 / 4 |
| other Total, other adverse events | 0 / 8 | 0 / 2 | 0 / 4 |
| serious Total, serious adverse events | 0 / 8 | 0 / 2 | 0 / 4 |
Outcome results
Primary
Change of Caregiver Burden as Measured by the Zarit Burden Interview (ZBI)
Caregiver 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).
Time frame: Immediately before hearing aid use and 6 weeks after the first day of hearing aid use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Audiologist-Based | Change of Caregiver Burden as Measured by the Zarit Burden Interview (ZBI) | -2.6 score on a scale | Standard Deviation 5.5 |
| Service-Only | Change of Caregiver Burden as Measured by the Zarit Burden Interview (ZBI) | -7 score on a scale | Standard Deviation 2.8 |
| Device-Only | Change of Caregiver Burden as Measured by the Zarit Burden Interview (ZBI) | -1 score on a scale | Standard Deviation 7.9 |
Primary
Change of Daily Activity as Measured by the Lawton Instrumental Activities of Daily Living Scale (IADL)
The 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).
Time frame: Immediately before hearing aid use and 6 weeks after the first day of hearing aid use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Audiologist-Based | Change of Daily Activity as Measured by the Lawton Instrumental Activities of Daily Living Scale (IADL) | 1 score on a scale | Standard Deviation 5 |
| Service-Only | Change of Daily Activity as Measured by the Lawton Instrumental Activities of Daily Living Scale (IADL) | 0 score on a scale | Standard Deviation 0 |
| Device-Only | Change of Daily Activity as Measured by the Lawton Instrumental Activities of Daily Living Scale (IADL) | 0 score on a scale | Standard Deviation 0 |
Primary
Hearing Aid Benefit as Measured by the International Outcomes Inventory for Hearing Aids (IOI-HA)
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).
Time frame: 6 weeks after the first day participants started using hearing aids.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Audiologist-Based | 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 |
| Service-Only | Hearing Aid Benefit as Measured by the International Outcomes Inventory for Hearing Aids (IOI-HA) | 3.4 score on a scale | Standard Deviation 0.3 |
| Device-Only | Hearing Aid Benefit as Measured by the International Outcomes Inventory for Hearing Aids (IOI-HA) | 3.7 score on a scale | Standard Deviation 0.6 |
Secondary
Change of Depression as Measured Using the Geriatric Depression Scale (GDS)
The 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).
Time frame: Immediately before hearing aid use and 6 weeks after the first day of hearing aid use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Audiologist-Based | Change of Depression as Measured Using the Geriatric Depression Scale (GDS) | -0.85 score on a scale | Standard Deviation 2.4 |
| Service-Only | Change of Depression as Measured Using the Geriatric Depression Scale (GDS) | 0.5 score on a scale | Standard Deviation 0.7 |
| Device-Only | Change of Depression as Measured Using the Geriatric Depression Scale (GDS) | -0.33 score on a scale | Standard Deviation 0.57 |
Secondary
Change of Hearing Handicap Measured by Hearing Handicap Inventory for the Elderly (HHIE) or Hearing Handicap Inventory for Adults (HHIA)
The 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).
Time frame: Immediately before hearing aid use and 6 weeks after the first day of hearing aid use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Audiologist-Based | 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 |
| Service-Only | Change of Hearing Handicap Measured by Hearing Handicap Inventory for the Elderly (HHIE) or Hearing Handicap Inventory for Adults (HHIA) | -14 score on a scale | Standard Deviation 11.3 |
| Device-Only | Change of Hearing Handicap Measured by Hearing Handicap Inventory for the Elderly (HHIE) or Hearing Handicap Inventory for Adults (HHIA) | -17.5 score on a scale | Standard Deviation 21.7 |
Secondary
Change of Quality of Life as Measured by the Alzheimer's Disease-Related Quality of Life (ADRQL)
The 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).
Time frame: Immediately before hearing aid use and 6 weeks after the first day of hearing aid use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Audiologist-Based | 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 |
| Service-Only | Change of Quality of Life as Measured by the Alzheimer's Disease-Related Quality of Life (ADRQL) | 13.8 score on a scale | Standard Deviation 30 |
| Device-Only | Change of Quality of Life as Measured by the Alzheimer's Disease-Related Quality of Life (ADRQL) | 1.25 score on a scale | Standard Deviation 3.9 |