NCT05399264

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 .

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Jun 2023

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Jun 2023Dec 2026

First Submitted

Initial submission to the registry

May 11, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
1 year until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

3 years

First QC Date

May 11, 2022

Last Update Submit

May 29, 2022

Conditions

Keywords

Auditory trainingWorking memorySpeech perceptionOlder adultsHearing loss

Outcome Measures

Primary Outcomes (2)

  • 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).

    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)

    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 Outcomes (3)

  • The CogState Battery (Changes are being assessed)

    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)

    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)

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

Study Arms (3)

Auditory-working memory training group

EXPERIMENTAL

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).

Behavioral: Auditory-working memory training program

Adaptive Auditory training group

ACTIVE COMPARATOR

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.

Behavioral: Auditory training program

Mindfulness training group

PLACEBO COMPARATOR

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.

Behavioral: Mindfulness training program

Interventions

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).

Auditory-working memory training group

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.

Adaptive Auditory 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.

Mindfulness training group

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 15937409BACKGROUND
  • 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.

    PMID: 21730859BACKGROUND
  • 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.

    PMID: 21241645BACKGROUND
  • 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.

    PMID: 25195607BACKGROUND
  • 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.

    PMID: 24023931BACKGROUND
  • 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.

    PMID: 15035561BACKGROUND

Related Links

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Chen Yuan, PhD

    The Education University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuan Chen, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2022

First Posted

June 1, 2022

Study Start

June 1, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

June 1, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share