An observational study in Alzheimer Disease and Hearing Loss, sponsored by Phonak AG, Switzerland. Completed at 1 site in Canada. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-11.
Sponsored by Phonak AG, Switzerland · Observational
There is a strong connection between hearing loss and cognitive impairment, particularly dementia, in old age. Worldwide, dementia affects approximately 5% of persons over the age of 65 years. Hearing loss is even more prevalent in old age, affecting an estimated one third of persons over the age of 65 years. Thus, there is likely a large degree of overlap between the impairments. Indeed, this overlap may influence older adults' everyday functioning, communication, social engagement and quality of life, as well as influencing the well-being of their family caregivers. This project will examine whether patients with hearing loss and Alzheimer's disease, the most common form of dementia, derive benefit the from hearing aids prescribed and fit to them following current best practice procedures in a geriatric audiology clinic. For the first time, a formal evaluation of the potential benefits of hearing aids for the patients' family caregivers will also be conducted.
Currently, five percent of individuals over the age of 65 suffer from Alzheimer's disease (AD) or a related dementia. Given that hearing loss affects approximately one third of individuals over the age of 65, it is likely that many persons with AD will also suffer from co-morbid hearing loss. Following this logic, a small proportion of the patients treated in a geriatric audiology clinic most likely have both AD and hearing loss. Little research has examined the use of hearing aids by persons with AD, and whether current audiologic rehabilitation can provide benefits for their cognitive, social, and communication functioning. In addition, given that caregiver burden is a huge issue for caregivers of persons with AD, this study will examine whether providing hearing aids to those with AD has concomitant benefits for their family caregivers (e.g., spouse, adult child).
The main research question in this study is: Will persons with AD demonstrate benefit from the use of hearing aids, where benefit is measured through questionnaires assessing activities of daily living, communication, and social functioning. We hypothesize that participants with AD in the intervention group (i.e., those who receive hearing aids) will have a larger improvement in overall functioning at the end of a one-month and three-month period than participants with AD in two control groups. Furthermore, we hypothesize that a group of cognitively normal control participants will demonstrate similar gains in functioning to those participants with AD. Finally, we hypothesize that a similar disparity in benefit between the intervention and control groups will be seen for the participants' caregivers. The specific objectives for this project are to determine, for people with AD if ... a) they can benefit from hearing aids based on common audiologic outcome measures, as well as measures of communication function and activities of daily living, and if such benefits depend on variations in current audiologic practice; b) they can benefit from hearing aids with regard to measures of severity of cognitive, behavioural and psychological symptoms of dementia and related caregiver burden; c) hearing aids can bolster their family caregivers' psychological well-being, relationship with, and perceived burden related to caring for and communicating with someone who suffers from both AD and hearing loss, and if specific issues related to communication and audiologic rehabilitation are identified as important by caregivers; and d) the beneficial effects of the hearing aid intervention on the person and their caregiver can be maintained at three months post-fitting.
A randomized control design will be used with three groups of AD patients randomly assigned to 1) intervention (immediate hearing aid fitting), 2) wait-list control (no hearing aid intervention) or 3) active control (no hearing aid intervention + using a new form of fitness technology). A final group of controls with normal cognition will also be tested. All participants will undergo an assessment of their cognition. They and their family caregivers will complete a battery of measures on at least three occasions: once right before the hearing aid fitting is completed to provide a baseline (1), as well as one-month (2) and three-months (3) post-fitting. Participants in the control groups will also complete a set of additional assessments corresponding to the timeline for the hearing aid fitting of participants in the interventions groups (i.e., they will complete 5 assessments rather than 3). In addition to the study sessions, all participants will also complete standard audiology appointments including hearing testing, hearing aid evaluation, hearing aid fitting, and hearing aid checking.
1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.
This study's enrollment of 25 is below the median of 87 across 270 observational studies indexed under Hearing Loss.
Browse Hearing Loss studies →Phonak AG, Switzerland is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Clients of geriatric hospital and residential living
Has a caregiver who...
Exclusion Criteria:
Has a caregiver who...
This group will consist of participants with Alzheimer's disease who receive treatment (Standard audiologic rehabilitation (incl. HI)) immediately and are followed over a three-month intervention period.
Device: Standard audiologic rehabilitation (incl. HI)
This group will consist of participants with normal cognition (i.e., no diagnosis of Alzheimer's disease) who receive treatment (Standard audiologic rehabilitation (incl. HI)) immediately and are followed over a three-month intervention period.
Device: Standard audiologic rehabilitation (incl. HI)
The intervention consists of standard audiologic rehabilitation in which participants are fit with at least one hearing instrument (HI).
Also known as: hearing aid
Client Oriented Scale of Improvement (COSI): Change over 3months
Measure of communication situations where the participant experiences difficulty (e.g., at church, in a noisy restaurant). Charts change in difficulty over time
Time frame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
Hearing Handicap Inventory of the Elderly (HHIE): Change over 3months
Measure of hearing and communication handicap
Time frame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
International Outcome Inventory for Hearing Aids (IOI-HA): Change over 2months
Measure of the effectiveness of hearing aid treatments
Time frame: 1st, 3rd month for AD_HI & NC_HI (4th, 6th month for controls AD_WaitC & AD_ActC resp.)
Self-Assessment of Communication (SAC): Change over 3months
Measure of difficulties caused by an individual's hearing los
Time frame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
Satisfaction with Amplification in Daily Life (SADL): Change over 2months
Measure of satisfaction with using hearing aids
Time frame: 1st, 3rd month for AD_HI & NC_HI (4th, 6th month for controls AD_WaitC & AD_ActC resp.)
Significant Other Assessment of Communication (SOAC): Change over 3months
Completed by significant other, measure of a communication partner's hearing difficulties
Time frame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
Significant Other Scale for Hearing Disability (SOS-Hear): Change over 3months
Measure of third-party disability experienced by spouses of older people with hearing impairment
Time frame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
Words-in-noise test (WIN): Change over 3months
Determines the signal-to-noise (SNR) threshold at which the person can correctly recognize 50% of the target words
Time frame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
Dichotic digits test (DDT): Change over 3months
Measure of central auditory processing
Time frame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
Montreal Cognitive Assessment (MoCA): Change over 3months
Measure of cognitive status
Time frame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
Hopkins Verbal-Learning Test (HVLT): Change over 3months
Measure of verbal memory
Time frame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
Brief Visuospatial Memory Test-R (BVMT): Change over 3months
Measure of visual memory
Time frame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
Behavioural Pathology in Alzheimer's disease (BEHAVE-AD): Change over 3months
Measure of problem behaviours demonstrated by individuals with dementia
Time frame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
Neuropsychiatric Inventory Brief (NPI-Q): Change over 3months
Measure of 12 neuropsychiatric symptoms commonly experienced by individuals with dementia
Time frame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
Positive and Negative Affect Schedule (PANAS): Change over 3months
Measure of mood assessing frequency of 10 positive and 10 negative emotions
Time frame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
Geriatric Depression Scale- Short Form (GDS-S): Change over 3months
Measure of depression in older adults
Time frame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
Bristol Activities of Daily Living Scale: Change over 3months
Measure of instrumental and basic activities of daily living over the past two weeks
Time frame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
Activity and Social Participation Assessment: Change over 3months
Measure of the frequency of specific activities
Time frame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
Quality of Life in Alzheimer's disease: Change over 3months
Measure of the domains of physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole
Time frame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
Practical Hearing Test- Revised: Change over 2months
Measure of objective ability to use hearing aids
Time frame: 1st, 3rd month for AD_HI & NC_HI (4th, 6th month for controls AD_WaitC & AD_ActC resp.)
Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids: Change over 3months
Measure of ability to use and maintain hearing aid
Time frame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
Perception of Conversation Index- Dementia of the Alzheimer Type: Change over 3months
Measure of caregivers' strategies for overcoming conversation difficulties
Time frame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
Relationship Satisfaction Questionnaire (RAS): Change over 3months
Measure of satisfaction with primary relationship
Time frame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
Social Support Questionnaire: Change over 3months
Measure of level of social support
Time frame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
Zarit Burden Interview- Short Form: Change over 3months
Measure of burden associated with behavioural impairments and the situation at home
Time frame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
Short-Form Health Survey-12 items: Change over 3months
Measure of functional health and well-being
Time frame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
Hours of hearing aid use: Change over 3months
Measure of how many hours the participant is wearing their hearing aid daily
Time frame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Phonak AG, Switzerland