Hearing LossNCT05399264
Efficacy of Auditory Training and Combined Auditory-working-memory Training in Improving Communication in Older Adults
A study testing Auditory-working memory training program, Auditory training program and Mindfulness training program in people with Hearing Loss, run by Education University of Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Auditory-working memory training program, Auditory training program and Mindfulness training program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jun 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Outer or middle ear pathologies.
- Wearing hearing aids or cochlear implants.
- No computers and internet access at home.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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 .
Read the 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.
- Conditions
- Hearing Loss
- Being tested
- Auditory-working memory training program, Auditory training program, Mindfulness training program
- Keywords
- Auditory training, Working memory, Speech perception, Older adults, Hearing loss
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory-working memory training programBehavioural
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 training programBehavioural
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.
Mindfulness training programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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. Receives: Behavioral: Mindfulness training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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)
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.
Measured: 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)
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).
Measured: 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)
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.
Measured: One week before the training, one day before the training, one day after the training, three months after the training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study startJun 2023 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Education University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chen Yuan, PhD, Principal investigator, The Education University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05399264
- Sponsor's protocol ID
- 2021-2022-0134
- Status last verified
- May 2022
- First submitted
- 11 May 2022
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15937409Anderson 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.
PubMed 21730859Anderson 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.
PubMed 21241645Carroll 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.
PubMed 25195607Zhong 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.
PubMed 24023931Gatehouse 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.
PubMed 15035561
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05399264
- Acronym / sponsor ID
- 2021-2022-0134
- Conditions
- Hearing Loss
- Keywords
- Auditory training, Working memory, Speech perception, Older adults, Hearing loss
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Education University of Hong KongUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Auditory-working memory training group | Experimental | Behavioral: Auditory-working memory training programThe 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). |
| Adaptive Auditory training group | Active comparator | Behavioral: Auditory training programThe 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. |
| Mindfulness training group | Placebo comparator | Behavioral: Mindfulness training programParticipants 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. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Outer or middle ear pathologies.
- Wearing hearing aids or cochlear implants.
- No computers and internet access at home.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auditory-working memory training programThe 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). | Behavioural | Auditory-working memory training group |
| Auditory training programDuring 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. | Behavioural | Adaptive Auditory training group |
| Mindfulness training programParticipants 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. | Behavioural | Mindfulness training group |
Primary outcome
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).
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.
3 secondary outcomes
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Background: PubMed 15937409Wong 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.
- Background: PubMed 21730859Anderson 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.
- Background: PubMed 21241645Anderson 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.
- Background: PubMed 25195607Carroll 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.
- Background: PubMed 24023931Zhong 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.
- Background: PubMed 15035561Gatehouse 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.
- platform used for the mindfulness trainingLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chen Yuan, PhD principal investigator
The Education University of Hong Kong
Questions about this trial
What is this clinical trial studying?
A study testing Auditory-working memory training program, Auditory training program and Mindfulness training program in people with Hearing Loss, run by Education University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuan Chen, PhD (59871023, cheny@eduhk.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05399264, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.