- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04021641
The Construction and Validation of CanSRINT
The Construction and Validation of Cantonese Sentence Recognition in Noise Test
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Hong Kong, Hong Kong, 0000
- The Chinese University of Hong Kong
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
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.
Description
Inclusion Criteria:
- Native in Catonese
Exclusion Criteria:
- Have overall cognitive and developmental impairment
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Participants with Typical Hearing
From 5 age groups from their 6 years of age to adulthood
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Measurement of speech recognition performance in noise
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Participants with Hearing Impairment
Participants with various degree of hearing impairment
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Measurement of speech recognition performance in noise
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Person Ability of Participants in Sentence Recognition in Noise
Time Frame: up to 1 month
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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.
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up to 1 month
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Item Difficulty of Test Items in Sentence Recognition in Noise
Time Frame: up to 3 years
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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.
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up to 3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Internal Consistency of Test Items
Time Frame: up to 3 years
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Cronbach's alpha or other relevant measurements will be used to estimate the consistency of the items on measuring the same dimension.
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up to 3 years
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Rater Reliability of Test Items
Time Frame: up to 1 month
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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.
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up to 1 month
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Test-Retest Reliability of Test Items
Time Frame: up to 1 month
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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.
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up to 1 month
|
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Content-related Evidence of Validity of Test Items
Time Frame: up to 3 years
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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.
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up to 3 years
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Construct-related Evidence of Validity of Test Items
Time Frame: up to 3 years
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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.
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up to 3 years
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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A New Sentence Recognition in Noise Test Tool Titled CanSRINT
Time Frame: up to 4 years
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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 published.
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up to 4 years
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ChineseUHK_CREC2018.639
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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