Alzheimer DiseaseHIADNCT02294513
Hearing Instruments in Alzheimer's Disease
An observational study of Alzheimer Disease and Hearing Loss, run by Phonak AG, Switzerland at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Hearing Loss
- What is being tested?
- Standard audiologic rehabilitation (incl. HI)
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2014to Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Clients of geriatric hospital and residential living
Who may be able to join
- Referred to the Audiology department by a physician with a confirmed diagnosis of Alzheimer's disease (or no diagnosis of AD if a normal cognition participant)
- Pure-tone threshold at 3 kHz in excess of 35 dB HL in the worse ear
- 60 years of age or older
- Able to read and communicate well in English
- Allow the researchers access to their medication list throughout the study to assess any changes in medications
- Willing to use one or more hearing aid(s) on a regular basis
Show all 14Show fewer
- Has a caregiver who…
- Is a family member
- Is over the age of 18
- Is able to read and communicate well in English.
- Accompanies participant to Baycrest for all necessary appointments
- Provides qualitative and quantitative assessments of the participant's everyday behaviours and functioning
- Is willing to learn and support the participant in using hearing aid(s), provide information on their own well-being and communication function
- If they currently use one or more hearing aid(s), have acquired said aid(s) at least one year prior and are using it/them in a stable fashion.
Who cannot join
- Suffered a traumatic brain injury or stroke within the past five years
- Has a history of untreated psychiatric illness
- Has an uncorrected deficit in visual acuity or an untreated visual medical issue (e.g., glaucoma, macular degeneration, diabetic retinopathy)
- Suffers from a neurological disorder (e.g., multiple sclerosis, epilepsy)
- Has any untreated medical conditions that could jeopardize participation in the study
- Has been taking medication for their cognitive impairment (e.g., cholinesterase inhibitor, NMDA receptor antagonists) for less than one month.
Show all 9Show fewer
- Has a caregiver who…
- Is not cognitively stable (e.g., has been diagnosed with mild cognitive impairment or dementia)
- Has a terminal medical or untreated psychiatric conditions that could jeopardize their participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hearing Intervention for Patients With Early-Stage Alzheimer's Disease: Determining the Benefits for Patients and Family Caregivers
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.
Read the detailed description
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.
- Conditions
- Alzheimer Disease, Hearing Loss
- Being tested
- Standard audiologic rehabilitation (incl. HI)
- Keywords
- Alzheimer disease, Dementia, Hearing loss, Correction of hearing impairment, Hearing aids, Communication, Family caregivers, Third-party disability
- Medical subject headings
- Alzheimer Disease, Hearing Loss, Dementia, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard audiologic rehabilitation (incl. HI)Device
Also called hearing aid
The intervention consists of standard audiologic rehabilitation in which participants are fit with at least one hearing instrument (HI).
| Study group | Role | What they receive |
|---|---|---|
| AD_HI | 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. Receives: Device: Standard audiologic rehabilitation (incl. HI) | |
| NC_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. Receives: Device: Standard audiologic rehabilitation (incl. HI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
Secondary outcomes (20)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phonak AG, Switzerland
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Toronto, Baycrest Centre for Geriatric Care
- Responsible party
- Sponsor
- Investigators
- Kathleen Pichora-Fuller, Prof., Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02294513
- Sponsor's protocol ID
- CHPHST101659-03HIAD
- Acronym
- HIAD
- Status last verified
- Apr 2017
- First submitted
- 31 Oct 2014
- Last updated
- 11 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hearing Intervention for Patients With Early-Stage Alzheimer's Disease: Determining the Benefits for Patients and Family Caregivers
- ClinicalTrials.gov ID
- NCT02294513
- Acronym / sponsor ID
- HIAD / CHPHST101659-03HIAD
- Conditions
- Alzheimer Disease, Hearing Loss
- Keywords
- Alzheimer disease, Dementia, Hearing loss, Correction of hearing impairment, Hearing aids, Communication, Family caregivers, Third-party disability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Phonak AG, SwitzerlandIndustry (pharma, biotech, devices)
- Collaborators
- University of Toronto, Baycrest Centre for Geriatric Care
- Study start
- Oct 2014 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 19 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AD_HI | – | Device: Standard audiologic rehabilitation (incl. HI)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. |
| NC_HI | – | 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Clients of geriatric hospital and residential living
Key inclusion criteria (14 listed)
- Referred to the Audiology department by a physician with a confirmed diagnosis of Alzheimer's disease (or no diagnosis of AD if a normal cognition participant)
- Pure-tone threshold at 3 kHz in excess of 35 dB HL in the worse ear
- 60 years of age or older
- Able to read and communicate well in English
- Allow the researchers access to their medication list throughout the study to assess any changes in medications
Key exclusion criteria (9 listed)
- Suffered a traumatic brain injury or stroke within the past five years
- Has a history of untreated psychiatric illness
- Has an uncorrected deficit in visual acuity or an untreated visual medical issue (e.g., glaucoma, macular degeneration, diabetic retinopathy)
- Suffers from a neurological disorder (e.g., multiple sclerosis, epilepsy)
- Has any untreated medical conditions that could jeopardize participation in the study
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 |
|---|---|---|
| Standard audiologic rehabilitation (incl. HI)Also: hearing aidThe intervention consists of standard audiologic rehabilitation in which participants are fit with at least one hearing instrument (HI). | Device | AD_HI, NC_HI |
Primary outcome
Client Oriented Scale of Improvement (COSI): Change over 3months
Time frame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
Measure of communication situations where the participant experiences difficulty (e.g., at church, in a noisy restaurant). Charts change in difficulty over time
Hearing Handicap Inventory of the Elderly (HHIE): Change over 3months
Time frame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
Measure of hearing and communication handicap
International Outcome Inventory for Hearing Aids (IOI-HA): Change over 2months
Time frame: 1st, 3rd month for AD_HI & NC_HI (4th, 6th month for controls AD_WaitC & AD_ActC resp.)
Measure of the effectiveness of hearing aid treatments
Self-Assessment of Communication (SAC): Change over 3months
Time frame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
Measure of difficulties caused by an individual's hearing los
Satisfaction with Amplification in Daily Life (SADL): Change over 2months
Time frame: 1st, 3rd month for AD_HI & NC_HI (4th, 6th month for controls AD_WaitC & AD_ActC resp.)
Measure of satisfaction with using hearing aids
Significant Other Assessment of Communication (SOAC): Change over 3months
Time frame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
Completed by significant other, measure of a communication partner's hearing difficulties
Significant Other Scale for Hearing Disability (SOS-Hear): Change over 3months
Time frame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
Measure of third-party disability experienced by spouses of older people with hearing impairment
20 secondary outcomes
Words-in-noise test (WIN): Change over 3months
Time frame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
Dichotic digits test (DDT): Change over 3months
Time frame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
Montreal Cognitive Assessment (MoCA): Change over 3months
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
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
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
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
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
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
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
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
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
Time frame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
Practical Hearing Test- Revised: Change over 2months
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
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
Time frame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
Relationship Satisfaction Questionnaire (RAS): Change over 3months
Time frame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
Social Support Questionnaire: Change over 3months
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
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
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
Time frame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
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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.
Kathleen Pichora-Fuller, Prof. principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Hearing Loss, run by Phonak AG, Switzerland at 1 site in Canada.
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 14 inclusion and 9 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 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Client Oriented Scale of Improvement (COSI): Change over 3months (time frame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2017.