Cognition Effects of Hearing Aids and Auditory Training in Older Age

NCT03112850 | Completed

• 1 other identifier: SHR Project 2016/159
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss, Sensorineural

Keywords

Crossover design; Randomized controlled trial; Aural rehabilitation intervention

Outcome Measures

Primary Outcomes (1)

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

  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.

  Change from baseline to six months

Secondary Outcomes (2)

• 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

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

Device: Hearing aid; Behavioral: Auditory Training

Group B

ACTIVE COMPARATOR

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

Device: Hearing aid; Behavioral: Auditory Training

Interventions

Hearing aid DEVICE

LOF hearing aid

Group A; Group B

Auditory Training BEHAVIORAL

Group A; Group B

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Swinburne University of Technology: lead

Study Sites (1)

Swinburne University of Technology

Melbourne, Victoria, 3122, Australia

Location

Related Publications (17)

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  PMID: 29572201 DERIVED

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Denny Meyer, PhD

  Swinburne University of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a randomised crossover trial with participants randomized into two equal groups to carry out separate crossover experiments. All participants will undergo an individualised auditory training for a period of 6 months, and will be randomly allocated to one of the following groups. 1. Participants who will be fitted with hearing aids for the first 3 months of auditory training program - Group A 2. Participants who will be fitted with hearing aids for the last 3 months of auditory training program - Group B Groups will be matched in terms of the degree of hearing loss with one member from each matched pair randomly assigned to Group A and the other member of each matched pair assigned to Group B. A random sequence of binary digits will be used for this purpose.

Study Record Dates

• First Submitted: April 1, 2017
• First Posted: April 13, 2017
• Study Start: December 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: September 7, 2018

Record last verified: 2018-09

Locations

AU (1)