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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03112850




Registration number
NCT03112850
Ethics application status
Date submitted
1/04/2017
Date registered
13/04/2017
Date last updated
7/09/2018

Titles & IDs
Public title
Cognition Effects of Hearing Aids and Auditory Training in Older Age
Scientific title
Investigating the Impact of Hearing Aid Use and Auditory Training on Cognition, Mood and Social Interaction in Older Adults With Hearing Loss
Secondary ID [1] 0 0
SHR Project 2016/159
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing Loss, Sensorineural 0 0
Condition category
Condition code
Ear 0 0 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Hearing aid

Active comparator: Group A - Participants who will be fitted with hearing aids for the first 3 months of 6 months auditory training program

Active comparator: Group B - Participants who will be fitted with hearing aids for the second 3 months of 6 months auditory training program


Treatment: Devices: Hearing aid
LOF hearing aid
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change over six months in SUCCAB performance (accuracy/reaction time) measures
Timepoint [1] 0 0
Change from baseline to six months
Secondary outcome [1] 0 0
Change in the Geriatric Depression Scale (GDS) aggregated into a single score
Timepoint [1] 0 0
Change from baseline to six months
Secondary outcome [2] 0 0
The Berkman-Syme Social Network Index aggregated into a single score
Timepoint [2] 0 0
Change from baseline to six months

Eligibility
Key inclusion criteria
1. Be aged between 50 and 90 years
2. Have good working knowledge of English
3. Mild or moderate symmetric sensorineural hearing loss with a pure-tone average (PTA) of thresholds at 0.5 - 6 kHz in both ears
4. Willing to wear hearing aids for three (3) months
5. Willing to undergo weekly auditory training for a period of six (6) months.
6. Submit written consent to participant in study
Minimum age
50 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any significant visual impairment that would prevent them from reading or performing computer based tasks.
2. Suspected cognitive impairment (defined as a score less or equal to 24 on the MMSE)
3. Severe or profound hearing loss

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2017
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Swinburne University of Technology - Melbourne
Recruitment postcode(s) [1] 0 0
3122 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Swinburne University of Technology
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Sensorineural type of hearing loss is the most common sensory deficit among older adults. Some of the psychosocial consequences of this condition include difficulty in understanding speech, depression and social isolation. Studies have shown that older adults with hearing loss show some age-related cognitive decline. There is no clinically proven method to predict the onset of this condition, as its occurrence is slow and progressive, affecting both ears equally. Although hearing aid use and auditory training have been proven as successful interventions to alleviate sensorineural hearing loss, no research has been designed to look at the effect of both hearing aid use coupled with auditory training on cognitive performance in older adults. This study will investigate whether wearing hearing aids will improve the impact of auditory training on cognition, mood and social interaction for older adults with sensorineural hearing loss.

This is a crossover trial targeting older adults between 50 and 90 years with either mild or moderate symmetric sensorineural hearing loss. Consented, willing participants will undergo a six month intensive auditory training program (active control), as a rigorous means of examining the impact hearing aid use has on a person's cognition, mood and social interaction. Participants will be assigned in random order to receive hearing aid (intervention) for either the first three or last three months of the six month auditory training program. Each participant will be tested at baseline, three and six months on a battery of computer based cognitive assessments, together with mood, and social engagement measures. Effectiveness of hearing aids and auditory training will be evaluated using an online speech perception test (SPT) and the Abbreviated Profile of Hearing Aid Benefit (APHAB) Inventory.

This study will investigate whether using a hearing aid coupled with auditory training can improve a person's cognition and learning abilities, relationships with family and friends, and quality of life. Results from the study will inform strategies for aural rehabilitation, hearing aid delivery and future hearing loss intervention trials.
Trial website
https://clinicaltrials.gov/study/NCT03112850
Trial related presentations / publications
Gates GA, Mills JH. Presbycusis. Lancet. 2005 Sep 24-30;366(9491):1111-20. doi: 10.1016/S0140-6736(05)67423-5.
Murphy CF, Fillippini R, Palma D, Zalcman TE, Lima JP, Schochat E. Auditory training and cognitive functioning in adult with traumatic brain injury. Clinics (Sao Paulo). 2011;66(4):713-5. doi: 10.1590/s1807-59322011000400030. No abstract available.
Amieva H, Ouvrard C, Giulioli C, Meillon C, Rullier L, Dartigues JF. Self-Reported Hearing Loss, Hearing Aids, and Cognitive Decline in Elderly Adults: A 25-Year Study. J Am Geriatr Soc. 2015 Oct;63(10):2099-104. doi: 10.1111/jgs.13649.
Lin FR, Yaffe K, Xia J, Xue QL, Harris TB, Purchase-Helzner E, Satterfield S, Ayonayon HN, Ferrucci L, Simonsick EM; Health ABC Study Group. Hearing loss and cognitive decline in older adults. JAMA Intern Med. 2013 Feb 25;173(4):293-9. doi: 10.1001/jamainternmed.2013.1868.
Davis A, Smith P, Ferguson M, Stephens D, Gianopoulos I. Acceptability, benefit and costs of early screening for hearing disability: a study of potential screening tests and models. Health Technol Assess. 2007 Oct;11(42):1-294. doi: 10.3310/hta11420.
Fischer ME, Cruickshanks KJ, Wiley TL, Klein BE, Klein R, Tweed TS. Determinants of hearing aid acquisition in older adults. Am J Public Health. 2011 Aug;101(8):1449-55. doi: 10.2105/AJPH.2010.300078. Epub 2011 Jun 16.
Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
Acar B, Yurekli MF, Babademez MA, Karabulut H, Karasen RM. Effects of hearing aids on cognitive functions and depressive signs in elderly people. Arch Gerontol Geriatr. 2011 May-Jun;52(3):250-2. doi: 10.1016/j.archger.2010.04.013. Epub 2010 May 15.
Blamey PJ, Blamey JK, Saunders E. Effectiveness of a teleaudiology approach to hearing aid fitting. J Telemed Telecare. 2015 Dec;21(8):474-8. doi: 10.1177/1357633X15611568.
Burke WJ, Roccaforte WH, Wengel SP. The short form of the Geriatric Depression Scale: a comparison with the 30-item form. J Geriatr Psychiatry Neurol. 1991 Jul-Sep;4(3):173-8. doi: 10.1177/089198879100400310.
Berkman LF, Syme SL. Social networks, host resistance, and mortality: a nine-year follow-up study of Alameda County residents. Am J Epidemiol. 1979 Feb;109(2):186-204. doi: 10.1093/oxfordjournals.aje.a112674.
Hardman RJ, Kennedy G, Macpherson H, Scholey AB, Pipingas A. A randomised controlled trial investigating the effects of Mediterranean diet and aerobic exercise on cognition in cognitively healthy older people living independently within aged care facilities: the Lifestyle Intervention in Independent Living Aged Care (LIILAC) study protocol [ACTRN12614001133628]. Nutr J. 2015 May 24;14:53. doi: 10.1186/s12937-015-0042-z.
Cox RM, Alexander GC. The abbreviated profile of hearing aid benefit. Ear Hear. 1995 Apr;16(2):176-86. doi: 10.1097/00003446-199504000-00005.
De Filippo CL, Scott BL. A method for training and evaluating the reception of ongoing speech. J Acoust Soc Am. 1978 Apr;63(4):1186-92. doi: 10.1121/1.381827.
Cunningham PB, Henggeler SW. Engaging multiproblem families in treatment: lessons learned throughout the development of multisystemic therapy. Fam Process. 1999 Fall;38(3):265-81. doi: 10.1111/j.1545-5300.1999.00265.x.
Liddle HA, Dakof GA, Parker K, Diamond GS, Barrett K, Tejeda M. Multidimensional family therapy for adolescent drug abuse: results of a randomized clinical trial. Am J Drug Alcohol Abuse. 2001 Nov;27(4):651-88. doi: 10.1081/ada-100107661.
Nkyekyer J, Meyer D, Blamey PJ, Pipingas A, Bhar S. Investigating the Impact of Hearing Aid Use and Auditory Training on Cognition, Depressive Symptoms, and Social Interaction in Adults With Hearing Loss: Protocol for a Crossover Trial. JMIR Res Protoc. 2018 Mar 23;7(3):e85. doi: 10.2196/resprot.8936.
Public notes

Contacts
Principal investigator
Name 0 0
Denny Meyer, PhD
Address 0 0
Swinburne University of Technology
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03112850