None listed
Conditions
Brief summary
Dementia is the leading cause of disability among Australians aged 65 or older and also the second leading cause of mortality. Nearly 400,000 Australians are currently living with dementia and, without a cure, this number is projected to reach 1.1 million over the next 30 years, with an estimated cost to the Australian community of more than $36.8 billion. Developing effective strategies to prevent dementia has become a global health priority, with projections suggesting that the total number of people living with dementia could be reduced by 13% (or about 400,000 people) if the onset of symptoms could be delayed by 10 years or more. The Lancet Dementia Taskforce concluded that hearing loss could account for 9% of all cases of dementia. Age-related hearing loss (ARHL) is a highly prevalent form of sensory impairment in later life, affecting 40% to 45% of people aged 65 years and 83% of those aged 70 years or above. At present, it is unclear if the reported association between hearing loss and dementia is causal and if the clinical remediation of sensory impairment could reduce the rate of cognitive decline among older adults at risk of dementia. The study will also explore the cost- effectiveness of the intervention compared to the control arm.
Interventions
Hearing Intervention:
The intervention consist of three parts: (i) hearing assessment and hearing aid (HA) discussion, (ii) HA fitting, verification and validation and (iii) HA review following daily use of HAs. The intervention will be carried out by a qualified audiologist according to the Australian Audiological Society Standards in a standardised sound proof booth.
Mode of delivery- face-to-face
Location: Ear Science Institute Australia- Lions Hearing Clinics in Nedlands, Subiaco, Mt Lawl
Hearing Intervention: The intervention consist of three parts: (i) hearing assessment and hearing aid (HA) discussion, (ii) HA fitting, verification and validation and (iii) HA review following daily use of HAs. The intervention will be carried out by a qualified audiologist according to the Australian Audiological Society Standards in a standardised sound proof booth. Mode of delivery- face-to-face Location: Ear Science Institute Australia- Lions Hearing Clinics in Nedlands, Subiaco, Mt Lawley, Joondalup and Bunbury. Part I: Hearing assessment and HA discussion Duration 1.15 hours. During the first appointment, the participant will complete (1) a comprehensive case history that contains information on medical and hearing history, ear infections, ear surgeries, head trauma, noise exposure, ototoxic drug exposure, visual and dexterity problems, tinnitus, vertigo, and cognition. (2) Client Oriented Scale of Improvement (COSI) goals for everyday listening situations and a standard hearing assessment. Finally, the audiologist will discuss with participants currently available technology of HAs that include suitable type and style of HAs and their cost, as well as participant’s daily listening expectations. The choice of hearing aid will be based on hearing loss, subject preference and ease of management. An explanation on what are hearing aids and how they work, what they are used for, how to use them, and questions and answers will be provided. Study participants receiving the intervention will also be given an educational booklet summarising the topics presented. (How we hear-prepared by Ear Science Institute Australia). A HA is a device designed to improve hearing by amplifying and acoustically modifying the sound to suit a person’s hearing loss. Current HA technology uses digital signal processing techniques to improve speech intelligibility and provide comfort for the user. Part II: HA fitting, real-ear verification and validation- within a week of attending the appointment part I- will be carried out by a qualified audiologist. Duration: 1 hour. The audiologist will program the HA and carry out the real-ear verification using real ear insertion gain (REIG) to ensure that appropriate amplification is provided to a person with hearing loss. The HA program will be fine-tuned to fit the participants’ every day listening demands using NAL-NL2 formula. Following, HA out-put verification, validation tasks will be carried out to determine that the participant is benefiting from the HAs. Validation includes asking the patient about sound quality, ear balance, comfort of the devices and finally a speech in quiet assessment using AB word list will also be carried out to determine that the participants is benefiting from the HAs. Adjustments can be made to the devices so that the patient is comfortable with the devices. Part III: HA review: 2 weeks after the HA fitting- will be conducted by a qualified audiologist Duration: 30 minutes. HA data logging information recorded in the software of the HA is analysed to ensure that the HA program provides the best solutions to the listening demands of the participant. Based on COSI goals, data logging information and feedback received from the participants, changes are made to the HA program. The participants will not attend any other assessments after part III. However, they will attend annual review appointments during which hearing will be assessed and changes to the hearing aid program will be carried out by the audiologist. Measuring adherence with treatment: Current HAs have a “log in” feature that records both the average number of hours and different listening environments in which the participant has used the HA. These data can be retrieved when the HA is connected to the program software, which will be done at all assessments. In addition, the participant will be asked to maintain a daily listening diary in which s/he records the number of hours the HA worn.
Sponsors
University of Western Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants will be older adults aged 70 years or older (cognitive decline is more pronounced later in life). Montreal Cognitive Assessment for the Hearing Impaired (MOCA-H) greater than or equal 18 and lesser than 26 (mild impairment). Better ear average hearing loss at 0.5, 1 & 2 kHz (3FAHL) equal to or greater than 23 dB or high frequency average hearing loss (2, 3 & 4 kHz) (HFAHL) equal to or greater than 40 dB as measured using air conduction pure-tone audiometry. We have followed the HA fitting criteria recommended by Office of Hearing Services Australia for older adults with ARHL. Fluent English speakers
Exclusion criteria
Impaired instrumental activities of daily living (IADL) due to cognitive deficits (requires assistance or is dependent in the use of telephone, shopping, housekeeping, laundry, transport, management of medications and finances) – i.e. has dementia or major neurocognitive disorder Meets clinical criteria for cochlear implantation (unaided bilateral sensorineural hearing loss greater than 70 dBHL, and open-set sentence scores in quiet in the worse ear less than 65% and in the better ear < 85% or open set phoneme scores in quiet in the worse ear less than 45% and in the better ear < 65% with optimized HA fitting Visual impairment that limits participant’s ability to read Times New Roman font size 16 (a requirement for 2 sentences of MOCA-H) Severe medical illness that limits the ability of the participant to attend appointments or sustain participation in the study for 24 months Plans to move away from the study area during the subsequent 24 months Unable or unwilling to provide written informed consent to participate Inability to complete the motor screening task (MOT) module of the Cambridge Neuropsychological Test Battery (CANTAB) due to visual impairment, inability to comprehend test instructions or inability to attend to the task due to dexterity problems.
Outcome results
None listed