Hearing Aid and Individuals With Cognitive Disorders

Alzheimer Disease 2 Due to Apoe4 Isoform Clinical Trial

Official title:

Impact of Hearing Aid Intervention on Individuals With Cognitive Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04049643
• Other study ID #: 201907763
• Secondary ID: 3R01DC015997-02S
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: May 1, 2025

Study information

• Verified date: May 2024
• Source: University of Iowa
• Contact: Yu-Hsiang Wu, PhD
• Phone: 319-335-8728
• Email: yu-hsiang-wu[@]uiowa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer Disease 2 Due to Apoe4 Isoform
• Cognition Disorders
• Cognitive Dysfunction
• Presbycusis
• Presbycusis, Bilateral

Intervention

Device:
• Audiologist-based fitting
Hearing aids will be fitted by audiologists using established procedures.
• 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 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.

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
Yu-Hsiang Wu	National Institute on Deafness and Other Communication Disorders (NIDCD), Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (8)

Adrait A, Perrot X, Nguyen MF, Gueugnon M, Petitot C, Collet L, Roux A, Bonnefoy M; ADPHA study group. Do Hearing Aids Influence Behavioral and Psychological Symptoms of Dementia and Quality of Life in Hearing Impaired Alzheimer's Disease Patients and Their Caregivers? J Alzheimers Dis. 2017;58(1):109-121. doi: 10.3233/JAD-160792. — View Citation

Hopper T, Slaughter SE, Hodgetts B, Ostevik A, Ickert C. Hearing Loss and Cognitive-Communication Test Performance of Long-Term Care Residents With Dementia: Effects of Amplification. J Speech Lang Hear Res. 2016 Dec 1;59(6):1533-1542. doi: 10.1044/2016_JSLHR-H-15-0135. — View Citation

Livingston G, Sommerlad A, Orgeta V, Costafreda SG, Huntley J, Ames D, Ballard C, Banerjee S, Burns A, Cohen-Mansfield J, Cooper C, Fox N, Gitlin LN, Howard R, Kales HC, Larson EB, Ritchie K, Rockwood K, Sampson EL, Samus Q, Schneider LS, Selbaek G, Teri L, Mukadam N. Dementia prevention, intervention, and care. Lancet. 2017 Dec 16;390(10113):2673-2734. doi: 10.1016/S0140-6736(17)31363-6. Epub 2017 Jul 20. No abstract available. — View Citation

Loughrey DG, Kelly ME, Kelley GA, Brennan S, Lawlor BA. Association of Age-Related Hearing Loss With Cognitive Function, Cognitive Impairment, and Dementia: A Systematic Review and Meta-analysis. JAMA Otolaryngol Head Neck Surg. 2018 Feb 1;144(2):115-126. doi: 10.1001/jamaoto.2017.2513. Erratum In: JAMA Otolaryngol Head Neck Surg. 2018 Feb 1;144(2):176. — View Citation

Mamo SK, Reed NS, Price C, Occhipinti D, Pletnikova A, Lin FR, Oh ES. Hearing Loss Treatment in Older Adults With Cognitive Impairment: A Systematic Review. J Speech Lang Hear Res. 2018 Oct 26;61(10):2589-2603. doi: 10.1044/2018_JSLHR-H-18-0077. — View Citation

Palmer CV, Adams SW, Bourgeois M, Durrant J, Rossi M. Reduction in caregiver-identified problem behaviors in patients with Alzheimer disease post-hearing-aid fitting. J Speech Lang Hear Res. 1999 Apr;42(2):312-28. doi: 10.1044/jslhr.4202.312. — View Citation

Palmer CV, Adams SW, Durrant JD, Bourgeois M, Rossi M. Managing hearing loss in a patient with Alzheimer disease. J Am Acad Audiol. 1998 Aug;9(4):275-84. — View Citation

Uhlmann RF, Larson EB, Rees TS, Koepsell TD, Duckert LG. Relationship of hearing impairment to dementia and cognitive dysfunction in older adults. JAMA. 1989 Apr 7;261(13):1916-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hearing aid benefit as measured by the International Outcomes Inventory for Hearing Aids - Significant Other (IOI-HA-SO)	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).	6-week post intervention
Primary	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).	6-week post intervention
Primary	Neuropsychiatric symptom as measured by the Neuropsychiatric Inventory-Questionnaire (NPI-Q)	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.	6-week post intervention
Primary	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).	6-week post intervention
Secondary	Hearing handicap as measured by Hearing Handicap Inventory for the Elderly - Spouse (HHIE-SP)	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).	6-week post intervention
Secondary	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).	6-week post intervention
Secondary	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)	6-week post intervention