Efficacy of Auditory Training and Combined Auditory-working-memory Training in Improving Communication in Older Adults

May 29, 2022 updated by: Education University of Hong Kong

Efficacy of Auditory Training and Combined Auditory-working-memory Training in Improving Communication and Cognition in Older Adults With Untreated Mild-to-moderate Sensorineural Hearing Impairment

Using a randomized controlled trial, we are going to examine whether a training program that incorporates both auditory training and working memory training (AT-WMT) would generate significantly better results in communication and cognition than an auditory training program and a mindfulness training program (active-control). Participants are 120 older adults (40 per group) with untreated mild-to-moderate sensorineural hearing impairment .

Study Overview

Detailed Description

There will be three training groups: the Auditory training (AT) group, the Auditory-working memory training (AT-WMT) group, and the control group (mindfulness training). All training programs are home-delivered, non-clinician-administered, and computer-based. That is, training will be self-paced and administered by the participants themselves at home using a computer. A software program (see Figure 2) has been created to facilitate the administration of the AT and AT-WMT. All training groups will spend one hour per day and five days per week for 4 weeks.

Before the training, two baseline test sessions (T1 and T2, a maximum of one week apart) will be used to account for the test-retest effects. The same measurements will be administered again one day (T3) and three months (T4) after completion of the training.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

51 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Native Cantonese speakers and having been living in Hong Kong for at least 20 years.
  • Aged between 55 and 80 years.
  • Normal cognitive function, as screened with the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) with a cutoff of 18/19.
  • Mild-to-moderate sensorineural HI, in which the four-frequency pure-tone average at 500, 1000, 2000, and 4000 Hz of the better ear is between 26 and 55 dB HL.

Exclusion Criteria:

  • Outer or middle ear pathologies.
  • Wearing hearing aids or cochlear implants.
  • No computers and internet access at home.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Auditory-working memory training group

The auditory-working memory training (AT-WMT) program is home-delivered, non-clinician-administered, and computer-based. That is, training will be self-paced and administered by the participants themselves at home using a computer. A software program has been created to facilitate the administration. Participants will spend one hour per day and five days per week for 4 weeks on training.

During the training, the following two adaptive tasks will be administered simultaneously: repeating the sentences masked by noise (i.e., AT component) and recalling the first or the final two words of all sentences in a given sentence set (i.e., WMT component).

The AT-WMT program is comprised of 1,200 daily used sentences either created or selected from newspapers, books, TV programs and magazines by the research assistants. The sentences are political-, cultural-, and religious-neutral sentences. Each of them contains 10 words. Noise was recorded from the upper and lower decks of a bus, in a café, a Chinese restaurant, an MTR (the Mass Transit Railway) carriage, and from a street.

During the training, the following two adaptive tasks will be administered simultaneously: repeating the sentences masked by noise (i.e., AT component) and recalling the first or the final two words of all sentences in a given sentence set (i.e., WMT component).

Active Comparator: Adaptive Auditory training group
The sentences used in the AT program are the same as those in the AT-WMT program. However, only the AT component (i.e., adaptive sentence perception in noise) of the AT-WMT program is required in the AT program. Participants do not need to recall the first or the final two words of the sentences. The same software in the experimental group will be used. Participants will spend one hour per day and five days per week for 4 weeks on training.
During the training, an adaptive speech-in-noise perception task will be administered. Specifically, the sentences in a sentence set will be presented binaurally using a headphone at a level the listeners felt is comfortable. The trainees are expected to immediately repeat each noise-masked sentence after hearing it. If they cannot repeat the sentence, then the sound intensity of the noise will be automatically decreased (step size = 2 dB) until the sentence can be correctly repeated. If the sentence can be repeated at the first attempt, then the intensity of the noise will be automatically increased by 2 dB in the next sentence. To provide feedback, the targeted sentence will be replaced by an asterisk and only shown after clicking the sentence.
Placebo Comparator: Mindfulness training group
Participants in this group will participate in a mindfulness training program using newlife.330 (Psychiatric Rehabilitation Association, 2018) which is a Cantonese online platform for self-guided mindfulness training. The time and computer use of the active-control group will match to those of the above two groups.
Participants in this group will participate in a mindfulness training program using newlife.330 (Psychiatric Rehabilitation Association, 2018) which is a Cantonese online platform for self-guided mindfulness training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Cantonese version of the Hearing in Noise Test (CHINT) (Changes are being assessed)
Time Frame: One week before the training, one day before the training, one day after the training, three months after the training
The Cantonese version of the Hearing in Noise Test (CHINT) (Wong & Soli, 2005) will be used to measure sentence perception in noise. The tool contains 12 lists of 20 sentences, and each sentence comprises 10 words. A high inter-list reliability has been previously demonstrated, which suggests that the lists are equivalent and, therefore, consistent results can be obtained using any of the lists (Wong et al., 2005).
One week before the training, one day before the training, one day after the training, three months after the training
The Cantonese version of the reading span test (CRST) (Changes are being assessed)
Time Frame: One week before the training, one day before the training, one day after the training, three months after the training

The Cantonese version of the reading span test (CRST) with dual task design will be used to measure WM. It was developed based on the German reading span test (Carroll et al., 2015). The reliability and validity of the CRST have been examined to confirm that the CRST is a suitable test for investigating verbal WM (Cheung, 2021).

The CRST comprises 54 six-word sentences. The sentences are presented in different set sizes (i.e., 3, 4, 5, and 6 sentences) in random order. The participants are expected to read aloud the sentences presented on a computer screen and judge whether the sentence is semantically correct. After reading aloud all sentences in a given sentence set, the participants will be asked to recall the first or last two words of each sentence in the set. The reading span score is based on the second task: the total number of words recalled. Approximately 20 minutes is needed to complete the test.

One week before the training, one day before the training, one day after the training, three months after the training

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The CogState Battery (Changes are being assessed)
Time Frame: One week before the training, one day before the training, one day after the training, three months after the training
Other cognitive functions (executive function, response inhibition, processing speed, and attention) will be examined using the CogState Battery, which is a sensitive computer-based assessment instrument. The test battery has been adapted for Chinese and its reliability and validity have been previously reported (Zhong et al., 2013). The test battery includes the following subtests and uses playing cards, digits, and pictures as stimuli: 1) One Back Test (short-term memory), 2) Groton Maze Learning Test (executive function), 3) Identification Test (Attention), 4) Go/No-Go Test (response inhibition), 5) International Digit Symbol Substitution Test-Symbols (processing speed). Each CogState subtask takes approximately 3-8 minutes. The entire CogState test battery is expected to be completed in 30-45 minutes.
One week before the training, one day before the training, one day after the training, three months after the training
The Speech, Spatial, and Qualities of Hearing scale (SSQHS) (Changes are being assessed)
Time Frame: One week before the training, one day before the training, one day after the training, three months after the training
The Speech, Spatial, and Qualities of Hearing scale (SSQHS) (Gatehouse & Noble, 2004) will be used to assess abilities and experience of hearing in different listening environments. The SSQHS is assessed using a self-report questionnaire that comprises 49 questions across the following three scales: 1) speech hearing (n = 14) for measuring the ability to recognize speech in a variety of competing contexts; 2) spatial hearing (n = 17) for assessing the ability of the directional, distance, and movement components of spatial hearing; 3) quality of hearing (n = 18) for evaluating the quality of hearing experience, including the clarity and naturalness of different speakers and everyday sounds, and ease of listening. The use of the SSQHS has been validated for Cantonese speakers (Lee, 2015).
One week before the training, one day before the training, one day after the training, three months after the training
Auditory Brainstem Responses to Complex Sounds (Changes are being assessed)
Time Frame: One week before the training, one day before the training, one day after the training, three months after the training
The stimulus, a 175 milliseconds /ji/ with Cantonese Tone 4 (low falling), will be used for recoding of subcortical neural responses to lexical tone. Stimuli with an interstimulus interval of 80 milliseconds will be presented in alternating polarity at 80 dB SPL and at 10 dB SNR with a six-speaker multi-talker noise through an insert earphone (ER-3, Etymotic Research). This type of noise and SNR were used in previous studies where significant relationships between SIN perception and cABRs were reported (Anderson & Kraus, 2010b; Anderson et al., 2011). Responses will be collected using a vertical electrode montage (ipsilateral earlobe reference, Cz active, and forehead ground) with the SmartEP (Intelligence Hearing Systems). An average of 6,000 sweeps will be made for responses to /ji4/ in quiet and multi-talker babble noise conditions, respectively.
One week before the training, one day before the training, one day after the training, three months after the training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Chen Yuan, PhD, The Education University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2023

Primary Completion (Anticipated)

June 1, 2026

Study Completion (Anticipated)

December 1, 2026

Study Registration Dates

First Submitted

May 11, 2022

First Submitted That Met QC Criteria

May 29, 2022

First Posted (Actual)

June 1, 2022

Study Record Updates

Last Update Posted (Actual)

June 1, 2022

Last Update Submitted That Met QC Criteria

May 29, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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