Presbycusis, BilateralNCT04049643
Hearing Aid and Individuals With Cognitive Disorders
A study testing Audiologist-based fitting, Service-only Fitting and Device-only fitting in people with Presbycusis, Bilateral and Alzheimer Disease 2 Due to Apoe4 Isoform, run by Yu-Hsiang Wu at 2 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Presbycusis, Bilateral, Alzheimer Disease 2 Due to Apoe4 Isoform, Mild Cognitive Impairment
- What is being tested?
- Audiologist-based fitting, Service-only Fitting and Device-only fitting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2019to 7 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Montreal Cognitive Assessment (MoCA) score lower than 25 points
- Adult-onset mild-to-moderate sensorineural hearing loss
Who cannot join
- Non-native English speaker
- Prior hearing aid experience
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Iowa
Iowa City, Iowa, 52242
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Impact of Hearing Aid Intervention on Individuals With Cognitive Disorders
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.
Read the 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.
- Conditions
- Presbycusis, Bilateral, Alzheimer Disease 2 Due to Apoe4 Isoform, Mild Cognitive Impairment
- Being tested
- Audiologist-based fitting, Service-only Fitting, Device-only fitting
- Keywords
- Presbycusis, Hearing aid, Alzheimer Disease, Mild Cognitive Impairment
- Medical subject headings
- Presbycusis, Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audiologist-based fittingDevice
Hearing aids will be fitted by audiologists using established procedures.
Service-only FittingDevice
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 fittingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Audiologist-Based | Active comparator | In this group, the audiologist-based fitting will be used to provide hearing aids. Receives: Device: Audiologist-based fitting |
| Service-Only | Experimental | In this group, hearing aids that have minimum amplification will be fitted by audiologists. Receives: Device: Service-only Fitting |
| Device-Only | Experimental | In this group, hearing aids will be provided with minimum services from audiologists. Receives: Device: Device-only fitting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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)
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).
Measured: 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)
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).
Measured: 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)
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).
Measured: Immediately before hearing aid use and 6 weeks after the first day of hearing aid use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start1 Dec 2019
- Primary completion7 Nov 2024
- Study completion7 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Presbycusis, BilateralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yu-Hsiang Wu
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University Medical Center, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor-investigator, Yu-Hsiang Wu, University of Iowa
- Investigators
- Yu-Hsiang Wu, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049643
- Sponsor's protocol ID
- 201907763
- Other IDs
- 3R01DC015997-02S1
- Status last verified
- Mar 2025
- First submitted
- 6 Aug 2019
- Last updated
- 17 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 2926927Palmer 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.
PubMed 9733237Palmer 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.
PubMed 10229449Mamo 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.
PubMed 30304320Loughrey 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.
PubMed 29222544Livingston 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.
PubMed 28735855Hopper 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.
PubMed 27973661Adrait 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.
PubMed 28269769
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Hearing Aid Intervention on Individuals With Cognitive Disorders
- ClinicalTrials.gov ID
- NCT04049643
- Acronym / sponsor ID
- 201907763
- Conditions
- Presbycusis, Bilateral, Alzheimer Disease 2 Due to Apoe4 Isoform, Mild Cognitive Impairment
- Keywords
- Presbycusis, Hearing aid, Alzheimer Disease, Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Yu-Hsiang WuUniversity, hospital or other
- Collaborators
- Vanderbilt University Medical Center, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 7 Nov 2024 (actual)
- Study completion
- 7 Nov 2024 (actual)
- First posted
- 8 Aug 2019 (actual)
- Results
- Posted 17 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Audiologist-Based | Active comparator | Device: Audiologist-based fittingIn this group, the audiologist-based fitting will be used to provide hearing aids. |
| Service-Only | Experimental | Device: Service-only FittingIn this group, hearing aids that have minimum amplification will be fitted by audiologists. |
| Device-Only | Experimental | Device: Device-only fittingIn this group, hearing aids will be provided with minimum services from audiologists. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Montreal Cognitive Assessment (MoCA) score lower than 25 points
- Adult-onset mild-to-moderate sensorineural hearing loss
Key exclusion criteria (2 listed)
- Non-native English speaker
- Prior hearing aid experience
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audiologist-based fittingHearing aids will be fitted by audiologists using established procedures. | Device | Audiologist-Based |
| Service-only FittingThis 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 | Service-Only |
| Device-only fittingThis 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. | Device | Device-Only |
Primary outcome
Hearing Aid Benefit as Measured by the International Outcomes Inventory for Hearing Aids (IOI-HA)
Time frame: 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)
Time frame: 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)
Time frame: 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).
3 secondary outcomes
Change of Hearing Handicap Measured by Hearing Handicap Inventory for the Elderly (HHIE) or Hearing Handicap Inventory for Adults (HHIA)
Time frame: 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)
Time frame: 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)
Time frame: Immediately before hearing aid use and 6 weeks after the first day of hearing aid use
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 2926927Uhlmann 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.
- Background: PubMed 9733237Palmer 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.
- Background: PubMed 10229449Palmer 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.
- Background: PubMed 30304320Mamo 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.
- Background: PubMed 29222544Loughrey 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.
- Background: PubMed 28735855Livingston 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.
- Background: PubMed 27973661Hopper 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.
- Background: PubMed 28269769Adrait 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.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Presbycusis, Bilateral
Enrolling by invitation
Hearing Screening in Adults Over 50 Years Old
Hearing Loss, Bilateral Sensorineural, Progressive, Hearing Loss, Bilateral (Causes Other Than Tumors)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Hsiang Wu, PhD principal investigator
University of Iowa
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audiologist-based fitting, Service-only Fitting and Device-only fitting in people with Presbycusis, Bilateral and Alzheimer Disease 2 Due to Apoe4 Isoform, run by Yu-Hsiang Wu at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hearing Aid Benefit as Measured by the International Outcomes Inventory for Hearing Aids (IOI-HA) (time frame: 6 weeks after the first day participants started using hearing aids.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04049643, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.