Hearing Aid and Individuals With Cognitive Disorders

Not Applicable

Completed

Conditions: Presbycusis, Bilateral
Alzheimer Disease 2 Due to Apoe4 Isoform
Mild Cognitive Impairment

Interventions: Device: Audiologist-based fitting
Device: Device-only fitting
Device: Service-only Fitting

Registration Number: NCT04049643

Lead Sponsor: Yu-Hsiang Wu

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 17

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Audiologist-Based	Audiologist-based fitting	In this group, the audiologist-based fitting will be used to provide hearing aids.
Device-Only	Device-only fitting	In this group, hearing aids will be provided with minimum services from audiologists.
Service-Only	Service-only Fitting	In this group, hearing aids that have minimum amplification will be fitted by audiologists.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).