Hearing LossNCT04021641
The Construction and Validation of CanSRINT
An observational study of Hearing Loss, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
An open-set sentence speech recognition in noise test in Cantonese Chinese, which is applicable on children and adults with hearing impairment, is proposed to be developed in this project. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Speech recognition in noise
- How many people
- 113 participants
- Where
- 1 siteHong Kong
- Study dates
- 29 Jun 2019to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants with typical hearing, from each of the 5 age groups from their 6 years of age to adulthood, will be recruited to contribute to the normative data of the proposed test. One hundred participants with various degree of hearing impairment will be recruited for the validation of the proposed new test.
Who may be able to join
- Native in Catonese
Who cannot join
- Have overall cognitive and developmental impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Construction and Validation of Cantonese Sentence Recognition in Noise Test
An open-set sentence speech recognition in noise test in Cantonese Chinese, which is applicable on children and adults with hearing impairment, is proposed to be developed in this project.
Read the detailed description
INTRODUCTION: Speech recognition in noise is an important aspect of human communication. One's speech recognition ability in noise is inevitably affected by any hearing impairment, and may only be quantified with specific language at an appropriate difficulty.
There is a niche among clinically available test materials between word recognition and 10- syllable sentence recognition in noise in Cantonese Chinese. Ten-syllable sentence items are commented to be too challenging to young children and elderly population. An assessment tool for pediatric patients, and the whole spectrum of patients with significant hearing impairment, compromised language or cognitive abilities, is deemed necessary. Both the research and clinical audiology communities need a valid and reliable outcome measurement tool for sentence recognition abilities in noise of the specific population.
An open-set sentence speech recognition in noise test in Cantonese Chinese, which is applicable on children and adults with hearing impairment, is proposed to be developed in this project to bridge the gap.
METHODS: Thirty three participants with typical hearing, from each of the 5 age groups from their 6 years of age to adulthood, will be recruited to contribute to the normative data of the proposed test. One hundred participants with various degree of hearing impairment will be recruited for the validation of the proposed new test as well.
A sentence pool of at least 150 sentence items will be constructed based on the basic sentence syntax in Cantonese Chinese. Each sentence item will be 7 syllables in length on average. The words used in the sentences will be words frequently used in daily life by both persons with typical hearing and hearing impairment. A 4-talker babble in Cantonese Chinese will be generated as the competing noise in this proposed new test.
OUTCOMES: By Rasch modelling, sentence items with high probability of consistently and accurately estimating sentence recognition ability in noise across different participants will be selected and distributed to a few parallel lists.
Rater and test-retest reliability of the test items and lists will be established.
Content-related and construct-related evidence of validity of lists will also be supported by psychometric analyses as well as expert consultation.
APPLICATION: A valid and reliable assessment tool, of sentence recognition ability in noise in Cantonese, applicable to persons with hearing sensitivity ranging from profound impairment to typical, in both the research and clinical audiology fields, will be constructed.
- Conditions
- Hearing Loss
- Being tested
- Speech recognition in noise
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speech recognition in noiseDiagnostic test
Measurement of speech recognition performance in noise
| Study group | Role | What they receive |
|---|---|---|
| Participants with Typical Hearing | From 5 age groups from their 6 years of age to adulthood Receives: Diagnostic Test: Speech recognition in noise | |
| Participants with Hearing Impairment | Participants with various degree of hearing impairment Receives: Diagnostic Test: Speech recognition in noise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Person Ability of Participants in Sentence Recognition in Noise
In accordance with Item Response Theory, the ability of individual participants in sentence recognition in noise, measured by the proposed new test, is generated through Rasch modelling or other relevant models.
Measured: up to 1 month
Item Difficulty of Test Items in Sentence Recognition in Noise
In accordance with Item Response Theory, the difficulty of individual proposed test items in sentence recognition in noise, contributed by all participants, is generated through Rasch modelling or other relevant models.
Measured: up to 3 years
Secondary outcomes (5)
Internal Consistency of Test Items
Cronbach's alpha or other relevant measurements will be used to estimate the consistency of the items on measuring the same dimension.
Measured: up to 3 years
Rater Reliability of Test Items
A portion of the test sessions will be scored twice by more than one raters. The intra-class correlation (ICC) or other relevant measurements will be employed to estimate rater reliability.
Measured: up to 1 month
Test-Retest Reliability of Test Items
A portion of participants will be tested twice. Pearson's coefficient of correlation or other relevant measurements will be computed to measure the correlation between the first and the second test results.
Measured: up to 1 month
Content-related Evidence of Validity of Test Items
Construction of sentence test items with elements from various relevant language corpus, based on the basic sentence syntax in Cantonese Chinese, and evaluated with reference to expert opinions, will be regarded as content-related evidence of the test item validity.
Measured: up to 3 years
Construct-related Evidence of Validity of Test Items
Unidimensionality and local independence, or other relevant measurements, in accordance with Item Response Theory, will be regarded as construct-related evidence of the test item validity.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start29 Jun 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iris H.-Y. NG, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04021641
- Sponsor's protocol ID
- ChineseUHK_CREC2018.639
- Status last verified
- Sep 2023
- First submitted
- 11 Jul 2019
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Construction and Validation of Cantonese Sentence Recognition in Noise Test
- ClinicalTrials.gov ID
- NCT04021641
- Acronym / sponsor ID
- ChineseUHK_CREC2018.639
- Conditions
- Hearing Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 29 Jun 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 16 Jul 2019 (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.
An open-set sentence speech recognition in noise test in Cantonese Chinese, which is applicable on children and adults with hearing impairment, is proposed to be developed in this project.
Detailed description
INTRODUCTION: Speech recognition in noise is an important aspect of human communication. One's speech recognition ability in noise is inevitably affected by any hearing impairment, and may only be quantified with specific language at an appropriate difficulty.
There is a niche among clinically available test materials between word recognition and 10- syllable sentence recognition in noise in Cantonese Chinese. Ten-syllable sentence items are commented to be too challenging to young children and elderly population. An assessment tool for pediatric patients, and the whole spectrum of patients with significant hearing impairment, compromised language or cognitive abilities, is deemed necessary. Both the research and clinical audiology communities need a valid and reliable outcome measurement tool for sentence recognition abilities in noise of the specific population.
An open-set sentence speech recognition in noise test in Cantonese Chinese, which is applicable on children and adults with hearing impairment, is proposed to be developed in this project to bridge the gap.
METHODS: Thirty three participants with typical hearing, from each of the 5 age groups from their 6 years of age to adulthood, will be recruited to contribute to the normative data of the proposed test. One hundred participants with various degree of hearing impairment will be recruited for the validation of the proposed new test as well.
A sentence pool of at least 150 sentence items will be constructed based on the basic sentence syntax in Cantonese Chinese. Each sentence item will be 7 syllables in length on average. The words used in the sentences will be words frequently used in daily life by both persons with typical hearing and hearing impairment. A 4-talker babble in Cantonese Chinese will be generated as the competing noise in this proposed new test.
OUTCOMES: By Rasch modelling, sentence items with high probability of consistently and accurately estimating sentence recognition ability in noise across different participants will be selected and distributed to a few parallel lists.
Rater and test-retest reliability of the test items and lists will be established.
Content-related and construct-related evidence of validity of lists will also be supported by psychometric analyses as well as expert consultation.
APPLICATION: A valid and reliable assessment tool, of sentence recognition ability in noise in Cantonese, applicable to persons with hearing sensitivity ranging from profound impairment to typical, in both the research and clinical audiology fields, will be constructed.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with Typical Hearing | – | Diagnostic Test: Speech recognition in noiseFrom 5 age groups from their 6 years of age to adulthood |
| Participants with Hearing Impairment | – | Diagnostic Test: Speech recognition in noiseParticipants with various degree of hearing impairment |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with typical hearing, from each of the 5 age groups from their 6 years of age to adulthood, will be recruited to contribute to the normative data of the proposed test. One hundred participants with various degree of hearing impairment will be recruited for the validation of the proposed new test.
Key inclusion criteria (1 listed)
- Native in Catonese
Key exclusion criteria (1 listed)
- Have overall cognitive and developmental impairment
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 |
|---|---|---|
| Speech recognition in noiseMeasurement of speech recognition performance in noise | Diagnostic test | Participants with Hearing Impairment, Participants with Typical Hearing |
Primary outcome
Person Ability of Participants in Sentence Recognition in Noise
Time frame: up to 1 month
In accordance with Item Response Theory, the ability of individual participants in sentence recognition in noise, measured by the proposed new test, is generated through Rasch modelling or other relevant models.
Item Difficulty of Test Items in Sentence Recognition in Noise
Time frame: up to 3 years
In accordance with Item Response Theory, the difficulty of individual proposed test items in sentence recognition in noise, contributed by all participants, is generated through Rasch modelling or other relevant models.
5 secondary outcomes
Internal Consistency of Test Items
Time frame: up to 3 years
Rater Reliability of Test Items
Time frame: up to 1 month
Test-Retest Reliability of Test Items
Time frame: up to 1 month
Content-related Evidence of Validity of Test Items
Time frame: up to 3 years
Construct-related Evidence of Validity of Test Items
Time frame: up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, run by Chinese University of Hong Kong at 1 site in 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Person Ability of Participants in Sentence Recognition in Noise (time frame: up to 1 month). 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?
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 21 Sep 2023.