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Hearing Aid and Individuals With Cognitive Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04049643
Recruitment Status : Recruiting
First Posted : August 8, 2019
Last Update Posted : February 25, 2020
Vanderbilt University Medical Center
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Yu-Hsiang Wu, University of Iowa

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.

Experimental: Service-Only
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.

Experimental: Device-Only
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.

Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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.

  4. 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).

Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • A diagnosis of mild or moderate Major Cognitive Disorder (e.g., Alzheimer disease)
  • Adult-onset mild-to-moderate sensorineural hearing loss
  • No prior hearing aid experience

Exclusion Criteria:

  • Non-native English speaker

Information from the National Library of Medicine

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 identifier (NCT number): NCT04049643

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Contact: Yu-Hsiang Wu, PhD 319-335-8728
Contact: Elizabeth Stangl, AuD 31-335-9758

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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         
Sponsors and Collaborators
Yu-Hsiang Wu
Vanderbilt University Medical Center
National Institute on Deafness and Other Communication Disorders (NIDCD)
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Principal Investigator: Yu-Hsiang Wu, PhD University of Iowa

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Responsible Party: Yu-Hsiang Wu, Associate Professor, University of Iowa Identifier: NCT04049643    
Other Study ID Numbers: 201907763
3R01DC015997-02S1 ( U.S. NIH Grant/Contract )
First Posted: August 8, 2019    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The proposed research will include data from a total of 240 participants with hearing loss recruited State of Iowa, State of Tennessee and surrounding areas. The final dataset will include laboratory data (e.g., speech recognition score) and self-reported demographic and behavioral data (e.g., questionnaire). Contact the principle investigator for data access.
Time Frame: The date will be available starting 6 months after publication of the main findings of the trial.
Access Criteria: Even though the final dataset will be stripped of identifiers prior to release for sharing, there remains the possibility of deductive disclosure of subjects with the survey data being collected. Thus, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate technologies; and (3) a commitment to destroying or returning the data after analyses are completed.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Yu-Hsiang Wu, University of Iowa:
Hearing aid
Alzheimer Disease
Additional relevant MeSH terms:
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Alzheimer Disease
Cognition Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Hearing Loss, Sensorineural
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations