Hearing Aid and Individuals With Cognitive Disorders
Impact of Hearing Aid Intervention on Individuals With Cognitive Disorders
2 other identifiers
interventional
17
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2019
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2019
CompletedFirst Posted
Study publicly available on registry
August 8, 2019
CompletedStudy Start
First participant enrolled
December 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 7, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 7, 2024
CompletedResults Posted
Study results publicly available
April 17, 2025
CompletedApril 17, 2025
March 1, 2025
4.9 years
August 6, 2019
March 18, 2025
March 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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).
6 weeks after the first day participants started using hearing aids.
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).
Immediately before hearing aid use and 6 weeks after the first day of hearing aid use
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).
Immediately before hearing aid use and 6 weeks after the first day of hearing aid use
Secondary Outcomes (3)
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
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
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
Study Arms (3)
Audiologist-Based
ACTIVE COMPARATORIn this group, the audiologist-based fitting will be used to provide hearing aids.
Service-Only
EXPERIMENTALIn this group, hearing aids that have minimum amplification will be fitted by audiologists.
Device-Only
EXPERIMENTALIn this group, hearing aids will be provided with minimum services from audiologists.
Interventions
Hearing aids will be fitted by audiologists using established procedures.
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.
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.
Eligibility Criteria
You may qualify if:
- Montreal Cognitive Assessment (MoCA) score lower than 25 points
- Adult-onset mild-to-moderate sensorineural hearing loss
You may not qualify if:
- Non-native English speaker
- Prior hearing aid experience
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Iowa
Iowa City, Iowa, 52242, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Related Publications (8)
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.
PMID: 2926927BACKGROUNDPalmer 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.
PMID: 9733237BACKGROUNDPalmer 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.
PMID: 10229449BACKGROUNDMamo 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.
PMID: 30304320BACKGROUNDLoughrey 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.
PMID: 29222544BACKGROUNDLivingston 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.
PMID: 28735855BACKGROUNDHopper 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.
PMID: 27973661BACKGROUNDAdrait 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.
PMID: 28269769BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This study faced challenges in recruiting subjects for the Service-Only and Device-Only groups. Since blinding was not feasible, some potential participants chose not to provide consent after learning their group assignment.
Results Point of Contact
- Title
- Dr. Yu-Hsiang Wu
- Organization
- The University of Iowa
Study Officials
- PRINCIPAL INVESTIGATOR
Yu-Hsiang Wu, PhD
University of Iowa
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 6, 2019
First Posted
August 8, 2019
Study Start
December 1, 2019
Primary Completion
November 7, 2024
Study Completion
November 7, 2024
Last Updated
April 17, 2025
Results First Posted
April 17, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- 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.
The proposed research will include data from participants with hearing loss recruited State of Iowa, State of Tennessee and surrounding areas. The final dataset will include self-reported demographic and behavioral data (e.g., questionnaire). Contact the principle investigator for data access.