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Clinical Trials/NCT03112850
NCT03112850CompletedNot Applicable

Investigating the Impact of Hearing Aid Use and Auditory Training on Cognition, Mood and Social Interaction in Older Adults With Hearing Loss

Swinburne University of Technology1 site in 1 country40 target enrollmentStarted: December 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Change over six months in SUCCAB performance (accuracy/reaction time) measures

Study Overview

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.

Detailed Description

Background:

Sensorineural hearing loss is the most common sensory deficit among older adults. There is no clinically proven method to predict the onset of this condition, as its occurrence is generally slow and progressive, affecting both ears equally. Recent studies have documented that hearing loss in older adults is independently associated with reduced cognitive functioning, mood and social interaction, and that hearing aid use and auditory training could improve cognitive abilities, social, emotional, psychological, and physical well-being of people. Despite the high prevalence of hearing loss in older adults, and the consequences for health outcomes, people are generally slow to acquire hearing aids, and almost two-thirds of older adults with hearing impairment do not use hearing aids. The popularity of auditory training has also declined in recent years and the focus of research has been shifted to only improving wearable amplification such as hearing aids. No research has been designed to specifically look at the effect of both hearing aid use coupled with auditory training on cognitive performance in older adults.

Study aim:

The aim of the current study is to investigate the impact of hearing aid use coupled with auditory training on mood, social relationships and cognitive functioning in a crossover intervention trial.

Study hypothesis:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
50 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Be aged between 50 and 90 years
  • Have good working knowledge of English
  • Mild or moderate symmetric sensorineural hearing loss with a pure-tone average (PTA) of thresholds at 0.5 - 6 kHz in both ears
  • Willing to wear hearing aids for three (3) months
  • Willing to undergo weekly auditory training for a period of six (6) months.
  • Submit written consent to participant in study

Exclusion Criteria

  • Any significant visual impairment that would prevent them from reading or performing computer based tasks.
  • Suspected cognitive impairment (defined as a score less or equal to 24 on the MMSE)
  • Severe or profound hearing loss

Arms & Interventions

Group A

Active Comparator

Participants who will be fitted with hearing aids for the first 3 months of 6 months auditory training program

Intervention: Hearing aid (Device)

Group A

Active Comparator

Participants who will be fitted with hearing aids for the first 3 months of 6 months auditory training program

Intervention: Auditory Training (Behavioral)

Group B

Active Comparator

Participants who will be fitted with hearing aids for the second 3 months of 6 months auditory training program

Intervention: Hearing aid (Device)

Group B

Active Comparator

Participants who will be fitted with hearing aids for the second 3 months of 6 months auditory training program

Intervention: Auditory Training (Behavioral)

Outcomes

Primary Outcomes

Change over six months in SUCCAB performance (accuracy/reaction time) measures

Time Frame: Change from baseline to six months

The SUCCAB contains a battery of eight cognitive domains namely Simple and Choice Reaction Times, Immediate and Delayed Recognition, Congruent and Incongruent Stroop colour-words, Spatial Working Memory and Contextual Memory.

Secondary Outcomes

  • Change in the Geriatric Depression Scale (GDS) aggregated into a single score(Change from baseline to six months)
  • The Berkman-Syme Social Network Index aggregated into a single score(Change from baseline to six months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Denny Meyer

Professor

Swinburne University of Technology

Study Sites (1)

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