Hearing Instruments in Alzheimer's Disease

NCT02294513 | Completed

• 1 other identifier: CHPHST101659-03HIAD
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Alzheimer Disease; Hearing Loss

Keywords

Alzheimer disease; Dementia; Hearing loss; Correction of hearing impairment; Hearing aids; Communication; Family caregivers; Third-party disability

Outcome Measures

Primary Outcomes (7)

• 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

  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

  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

  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

  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

  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

  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

  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

  0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)

• Dichotic digits test (DDT): Change over 3months

  0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)

• Montreal Cognitive Assessment (MoCA): Change over 3months

  0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)

• Hopkins Verbal-Learning Test (HVLT): Change over 3months

  0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)

• Brief Visuospatial Memory Test-R (BVMT): Change over 3months

  0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)

Study Arms (2)

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.

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.

Device: Standard audiologic rehabilitation (incl. HI)

Interventions

Standard audiologic rehabilitation (incl. HI) DEVICE

The intervention consists of standard audiologic rehabilitation in which participants are fit with at least one hearing instrument (HI).

Also known as: hearing aid

AD_HI; NC_HI

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Clients of geriatric hospital and residential living

You may qualify if:

• 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
• 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
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Phonak AG, Switzerland: lead
• University of Toronto: collaborator
• Baycrest Centre for Geriatric Care: collaborator

Study Sites (1)

Baycrest Center of Geriatric Care

Toronto, Ontario, M6A 2E1, Canada

Location

MeSH Terms

Conditions

Alzheimer Disease; Hearing Loss; Dementia; Communication

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies; Sensory Aids

Study Officials

• Kathleen Pichora-Fuller, Prof.

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2014
• First Posted: November 19, 2014
• Study Start: October 1, 2014
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: April 11, 2017

Record last verified: 2017-04

Locations

CA (1)