NCT04021641

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
113

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 29, 2019

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 16, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

3.5 years

First QC Date

July 11, 2019

Last Update Submit

September 18, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    up to 3 years

Secondary Outcomes (5)

  • Internal Consistency of Test Items

    up to 3 years

  • Rater Reliability of Test Items

    up to 1 month

  • Test-Retest Reliability of Test Items

    up to 1 month

  • Content-related Evidence of Validity of Test Items

    up to 3 years

  • Construct-related Evidence of Validity of Test Items

    up to 3 years

Other Outcomes (1)

  • A New Sentence Recognition in Noise Test Tool Titled CanSRINT

    up to 4 years

Study Arms (2)

Participants with Typical Hearing

From 5 age groups from their 6 years of age to adulthood

Diagnostic Test: Speech recognition in noise

Participants with Hearing Impairment

Participants with various degree of hearing impairment

Diagnostic Test: Speech recognition in noise

Interventions

Measurement of speech recognition performance in noise

Participants with Hearing ImpairmentParticipants with Typical Hearing

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Native in Catonese

You may not qualify if:

  • Have overall cognitive and developmental impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, 0000, Hong Kong

Location

MeSH Terms

Conditions

Hearing Loss

Interventions

Noise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

SoundRadiation, NonionizingRadiationPhysical PhenomenaEnvironmentEcological and Environmental PhenomenaBiological PhenomenaEnvironment and Public HealthEnvironmental PollutionPublic Health

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Otorhinolaryngology, Head and Neck Surgery

Study Record Dates

First Submitted

July 11, 2019

First Posted

July 16, 2019

Study Start

June 29, 2019

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations