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Trial registered on ANZCTR


Registration number
ACTRN12618001278224p
Ethics application status
Submitted, not yet approved
Date submitted
19/06/2018
Date registered
30/07/2018
Date last updated
30/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Hearing Aids to Support Cognitive Functions of Older Adults at Risk of Dementia
Scientific title
Could hearing loss correction through the use of hearing aids decrease the 12-month rate of cognitive decline among older adults at risk of dementia?
Secondary ID [1] 295210 0
Nil
Universal Trial Number (UTN)
U1111-1215-6715
Trial acronym
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Hearing Loss 308351 0
Cognitive Impairment 308352 0
Dementia 308353 0
Condition category
Condition code
Ear 307351 307351 0 0
Deafness
Neurological 307352 307352 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 301549 0
Treatment: Devices
Comparator / control treatment
Participants who meet criteria for inclusion in the study will be randomly assigned to either the experimental (A) or control (B) group. Group A participants will receive intervention (hearing aids) immediately after the baseline assessment, whereas group B participants will receive intervention 12 months later. All participants will be informed that if they get randomly allocated to group B, they will have to wait 12 months to receive the treatment. Those who prefer to receive HA immediately without having to wait 12 months will be given the option to opt out from the study. The control group will also undergo the same treatment as the experimental group.
Control group
Active

Outcomes
Primary outcome [1] 306316 0
Global cognitive functions- Montreal Cognitive Assessment for the Hearing Impaired (MoCA-H).
Timepoint [1] 306316 0
52 weeks after the baseline (primary end point) and 104 weeks after the baseline
Secondary outcome [1] 348162 0
1. Cognitive functions - executive functions, episodic memory, spatial working memory & short-term visual recognition memory will be assessed using Cambridge Neuropsychological Test Battery (CANTAB).
Timepoint [1] 348162 0
52 and 104 weeks after the baseline
Secondary outcome [2] 348580 0
2. Health status and Quality of life: Short form survey (SF-12)
Timepoint [2] 348580 0
52 weeks and 104 weeks after the baseline
Secondary outcome [3] 348581 0
3. Physical function: Functional Comorbidity Index (FCI)
Timepoint [3] 348581 0
52 weeks and 104 weeks after the baseline
Secondary outcome [4] 348582 0
4.Depressive symptoms: Patient Health Questionnaire (PHQ-9)
Timepoint [4] 348582 0
52 weeks and 104 weeks after the baseline
Secondary outcome [5] 348583 0
5. Anxiety symptoms: Geriatric Anxiety Inventory (GAI)
Timepoint [5] 348583 0
52 weeks and 104 weeks after the baseline
Secondary outcome [6] 348584 0
6. Daily living function: Lawton & Brody Instrumental Activities of Daily Living (IADL)
Timepoint [6] 348584 0
52 weeks and 104 weeks after the baseline
Secondary outcome [7] 348585 0
7. Social Support and interaction: Berkman Syme Social Network Index (SNI)
Timepoint [7] 348585 0
52 weeks and 104 weeks after the baseline
Secondary outcome [8] 348586 0
8. Loneliness: de Jong Gierveld Loneliness scale
Timepoint [8] 348586 0
52 weeks and 104 weeks after the baseline
Secondary outcome [9] 348587 0
9. Physical function-grip strength-will be measured using a hand held dynamometer
Timepoint [9] 348587 0
52 weeks and 104 weeks after the baseline
Secondary outcome [10] 348588 0
10. Psychological and social adjustment problems resulting from hearing loss: Hearing Handicap Inventory of the Elderly (HHIE)
Timepoint [10] 348588 0
52 weeks and 104 weeks after the baseline
Secondary outcome [11] 348589 0
11. Effectiveness of the HAs application: International Outcome Inventory for HAs (IOI-HA)
Timepoint [11] 348589 0
52 weeks and 104 weeks after the baseline
Secondary outcome [12] 350057 0
Health economic cost analysis: We will use administrative health linkage data to ascertain contact with hospital services (planned and unplanned), the reason for contact and length of stay and procedures. Costs will be calculated according to the Medicare Medical Schedule.
Timepoint [12] 350057 0
52 weeks and 104 weeks

Eligibility
Key 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
Minimum age
70 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Once a participant consents and is enrolled, s/he will be automatically ascribed a number and group membership (intervention or control) at the central administration site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)The computer generated randomisation sequence will be stratified by the severity of the hearing loss (mild to moderate vs severe) based on the results of the hearing assessment. Each stratification block will be associated with a random sequence of numbers assigned to the intervention and control groups in random permuted blocks of 6, 8 or 10. This sequence will be stored in a password-protected server housed at the University of Western Australia and will be managed by a biostatistician not involved in this project.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size: Based on delayed matching to sample percent correct pilot test data, a total of 140 participants will be required (70 in each group; effect size d = 0.28, a = .05, power .90). To account for 25% of attrition over time, a total of 180 participants will be recruited.

All analyses will follow CONSORT guidelines. We will use standard descriptive statistics to compare basic socio-demographic and clinical data across treatment arms. We will use multilevel mixed models to investigate changes in cognitive and other scale scores over time. Mixed models provide estimates that are ‘intention-to-treat’ and allow for the investigation of interactions between group and time effects, as well as for the adjustment of possible imbalances between the groups following the randomisation. We will use imputed chain equations if loss to follow up exceeds 25%. All probability tests will be two-tailed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 11190 0
Lions Hearing Clinic - Mount Lawley - Mount Lawley
Recruitment hospital [2] 11191 0
Lions Hearing Clinic - Nedlands - Nedlands
Recruitment hospital [3] 11192 0
Lions Hearing Clinic - Joondalup - Joondalup
Recruitment hospital [4] 11193 0
Lions Hearing Clinic - Winthrop - Winthrop
Recruitment hospital [5] 11194 0
Lions Hearing Clinic - Bunbury - Bunbury
Recruitment postcode(s) [1] 23026 0
6050 - Mount Lawley
Recruitment postcode(s) [2] 23035 0
6009 - Nedlands
Recruitment postcode(s) [3] 23036 0
6027 - Joondalup
Recruitment postcode(s) [4] 23037 0
6150 - Winthrop
Recruitment postcode(s) [5] 23038 0
6230 - Bunbury

Funding & Sponsors
Funding source category [1] 299796 0
Other
Name [1] 299796 0
Equity Trustees Charitable Foundation-The Ron & Peggy Bell Family Legacy
Address [1] 299796 0
Level 24 Allendale Square
77 St Georges Terrace
Perth WA 6000
Australia
Country [1] 299796 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
35 Stirling Hwy, Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 299146 0
Other Collaborative groups
Name [1] 299146 0
Western Australian Centre for Health & Ageing.
Address [1] 299146 0
Level 6, Medical Research Foundation, 50 Murray St (Rear - G1 block), Perth, WA 6000, Australia.
Country [1] 299146 0
Australia
Secondary sponsor category [2] 299192 0
Other Collaborative groups
Name [2] 299192 0
Ear Science Institute Australia
Address [2] 299192 0
1 Salvado Road,Subiaco WA 6008
Country [2] 299192 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 300681 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 300681 0
Human Research office
Research Enterprise, University of Western Australia
35 Stirling Highway
Perth WA 6009 Australia
Ethics committee country [1] 300681 0
Australia
Date submitted for ethics approval [1] 300681 0
19/06/2018
Approval date [1] 300681 0
Ethics approval number [1] 300681 0
RA/4/20/4641

Summary
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.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2785 2785 0 0
Attachments [2] 2786 2786 0 0
Attachments [3] 2787 2787 0 0
Attachments [4] 2788 2788 0 0

Contacts
Principal investigator
Name 84454 0
Dr Dona MP Jayakody
Address 84454 0
Ear Science Institute Australia
1 Salvado Road,
Subiaco WA 6008
Country 84454 0
Australia
Phone 84454 0
+61864570541
Fax 84454 0
Email 84454 0
dona.jayakody@earscience.org.au
Contact person for public queries
Name 84455 0
Dr Dona MP Jayakody
Address 84455 0
Ear Science Institute Australia
1 Salvado Road,
Subiaco WA 6008
Country 84455 0
Australia
Phone 84455 0
+61864570541
Fax 84455 0
Email 84455 0
dona.jayakody@earscience.org.au
Contact person for scientific queries
Name 84456 0
Dr Dona MP Jayakody
Address 84456 0
Ear Science Institute Australia
1 Salvado Road,
Subiaco WA 6008
Country 84456 0
Australia
Phone 84456 0
+61864570541
Fax 84456 0
Email 84456 0
dona.jayakody@earscience.org.au

No information has been provided regarding IPD availability
How or where can supporting documents be obtained?
Type [1] 2601 0
Ethical approval
Citation [1] 2601 0
Link [1] 2601 0
Email [1] 2601 0
Other [1] 2601 0
Summary results
No Results