Hearing Aid and Individuals With Cognitive Disorders
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|ClinicalTrials.gov Identifier: NCT04049643|
Recruitment Status : Recruiting
First Posted : August 8, 2019
Last Update Posted : February 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Presbycusis, Bilateral Alzheimer Disease 2 Due to Apoe4 Isoform||Device: Audiologist-based fitting Device: Service-only Fitting Device: Device-only fitting||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Impact of Hearing Aid Intervention on Individuals With Cognitive Disorders|
|Actual Study Start Date :||December 1, 2019|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||May 31, 2021|
Active Comparator: Audiologist-Based
In this group, the audiologist-based fitting will be used to provide hearing aids.
Device: Audiologist-based fitting
Hearing aids will be fitted by audiologists using established procedures.
In this group, hearing aids that have minimum amplification will be fitted by audiologists.
Device: 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.
In this group, hearing aids will be provided with minimum services from audiologists.
Device: 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 - Significant Other (IOI-HA-SO) [ Time Frame: 6-week post intervention ]The IOI-HA-SO, which is an extension of the widely used questionnaire IOI-HA, was designed to inquire about effects of the partner's hearing loss on the significant other. The score ranges from 1 (less benefit) to 5 (more benefit).
- Daily activity as measured by the Lawton Instrumental Activities of Daily Living Scale (IADL) [ Time Frame: 6-week post intervention ]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).
- Neuropsychiatric symptom as measured by the Neuropsychiatric Inventory-Questionnaire (NPI-Q) [ Time Frame: 6-week post intervention ]The NPI-Q is a clinical instrument for briefly evaluating behavioral and psychological symptoms of dementia. Scores of lower than 20 indicate mild problem and higher than 50 indicate severe disturbance.
- Caregiver burden as measured by the Zarit Burden Interview (ZBI) [ Time Frame: 6-week post intervention ]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).
- Hearing handicap as measured by Hearing Handicap Inventory for the Elderly - Spouse (HHIE-SP) [ Time Frame: 6-week post intervention ]The HHIE-SP, which is a modified version of the HHIE for use with spouses, is a retrospective questionnaire. The HHIE-SP allows spouses (or caregiver) to report their perception about how hearing loss affect their partners' activity limitations and participation restrictions. score ranges from 0 (no handicap) to 24 (more handicap).
- Quality of life as measured by the Alzheimer's Disease-Related Quality of Life (ADRQL) [ Time Frame: 6-week post intervention ]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).
- Depression as measured using the Geriatric Depression Scale (GDS) [ Time Frame: 6-week post intervention ]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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04049643
|Contact: Yu-Hsiang Wu, PhDemail@example.com|
|Contact: Elizabeth Stangl, AuDfirstname.lastname@example.org|
|United States, Iowa|
|University of Iowa||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Yu-Hsiang Wu, PhD|
|United States, Tennessee|
|Vanderbilt University Medical Center||Recruiting|
|Nashville, Tennessee, United States, 37232|
|Contact: Todd Ricketts, PhD|
|Principal Investigator:||Yu-Hsiang Wu, PhD||University of Iowa|