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

Primary Purpose

Hearing Loss

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Auditory-working memory training program
Auditory training program
Mindfulness training program
Sponsored by
Education University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss focused on measuring Auditory training, Working memory, Speech perception, Older adults, Hearing loss

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Placebo Comparator

    Arm Label

    Auditory-working memory training group

    Adaptive Auditory training group

    Mindfulness training group

    Arm Description

    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 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.

    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.

    Outcomes

    Primary Outcome Measures

    The Cantonese version of the Hearing in Noise Test (CHINT) (Changes are being assessed)
    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).
    The Cantonese version of the reading span test (CRST) (Changes are being assessed)
    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.

    Secondary Outcome Measures

    The CogState Battery (Changes are being assessed)
    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.
    The Speech, Spatial, and Qualities of Hearing scale (SSQHS) (Changes are being assessed)
    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).
    Auditory Brainstem Responses to Complex Sounds (Changes are being assessed)
    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.

    Full Information

    First Posted
    May 11, 2022
    Last Updated
    May 29, 2022
    Sponsor
    Education University of Hong Kong
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05399264
    Brief Title
    Efficacy of Auditory Training and Combined Auditory-working-memory Training in Improving Communication in Older Adults
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2023 (Anticipated)
    Primary Completion Date
    June 2026 (Anticipated)
    Study Completion Date
    December 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Education University of Hong Kong

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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 .
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hearing Loss
    Keywords
    Auditory training, Working memory, Speech perception, Older adults, Hearing loss

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Auditory-working memory training group
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Adaptive Auditory training group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Mindfulness training group
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Auditory-working memory training program
    Intervention Description
    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).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Auditory training program
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mindfulness training program
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    The Cantonese version of the Hearing in Noise Test (CHINT) (Changes are being assessed)
    Description
    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).
    Time Frame
    One week before the training, one day before the training, one day after the training, three months after the training
    Title
    The Cantonese version of the reading span test (CRST) (Changes are being assessed)
    Description
    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.
    Time Frame
    One week before the training, one day before the training, one day after the training, three months after the training
    Secondary Outcome Measure Information:
    Title
    The CogState Battery (Changes are being assessed)
    Description
    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.
    Time Frame
    One week before the training, one day before the training, one day after the training, three months after the training
    Title
    The Speech, Spatial, and Qualities of Hearing scale (SSQHS) (Changes are being assessed)
    Description
    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).
    Time Frame
    One week before the training, one day before the training, one day after the training, three months after the training
    Title
    Auditory Brainstem Responses to Complex Sounds (Changes are being assessed)
    Description
    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.
    Time Frame
    One week before the training, one day before the training, one day after the training, three months after the training

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yuan Chen, PhD
    Phone
    59871023
    Email
    cheny@eduhk.hk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chen Yuan, PhD
    Organizational Affiliation
    The Education University of Hong Kong
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    15937409
    Citation
    Wong LL, Soli SD. Development of the Cantonese Hearing In Noise Test (CHINT). Ear Hear. 2005 Jun;26(3):276-89. doi: 10.1097/00003446-200506000-00004.
    Results Reference
    background
    PubMed Identifier
    21730859
    Citation
    Anderson S, Parbery-Clark A, Yi HG, Kraus N. A neural basis of speech-in-noise perception in older adults. Ear Hear. 2011 Nov-Dec;32(6):750-7. doi: 10.1097/AUD.0b013e31822229d3.
    Results Reference
    background
    PubMed Identifier
    21241645
    Citation
    Anderson S, Kraus N. Sensory-cognitive interaction in the neural encoding of speech in noise: a review. J Am Acad Audiol. 2010 Oct;21(9):575-85. doi: 10.3766/jaaa.21.9.3.
    Results Reference
    background
    PubMed Identifier
    25195607
    Citation
    Carroll R, Meis M, Schulte M, Vormann M, Kiessling J, Meister H. Development of a German reading span test with dual task design for application in cognitive hearing research. Int J Audiol. 2015 Feb;54(2):136-41. doi: 10.3109/14992027.2014.952458. Epub 2014 Sep 8.
    Results Reference
    background
    PubMed Identifier
    24023931
    Citation
    Zhong N, Jiang H, Wu J, Chen H, Lin S, Zhao Y, Du J, Ma X, Chen C, Gao C, Hashimoto K, Zhao M. Reliability and validity of the CogState battery Chinese language version in schizophrenia. PLoS One. 2013 Sep 2;8(9):e74258. doi: 10.1371/journal.pone.0074258. eCollection 2013.
    Results Reference
    background
    PubMed Identifier
    15035561
    Citation
    Gatehouse S, Noble W. The Speech, Spatial and Qualities of Hearing Scale (SSQ). Int J Audiol. 2004 Feb;43(2):85-99. doi: 10.1080/14992020400050014.
    Results Reference
    background
    Links:
    URL
    https://newlife330.hk/
    Description
    platform used for the mindfulness training

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

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