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CAM-FMHT: Validation Of Cambodia Version of Five Minutes Hearing Test

Sponsor
Khon Kaen University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05736055
Collaborator
(none)
481
Enrollment
33
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Seek the simple tool as questionnaire for screening hearing loss. The FMHT was developed by American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS). It is a standard hearing questionnaire. So, we plan to translate the FMHT into Cambodian language and validate by comparing its result with those of audiometry.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Cambodia Version Five Minutes Hearing Test

Detailed Description

Primary Objective:

To assess sensitivity of the FMHT in Cambodia version (CAM-FMHT) compared with the standard audiometry

Secondary Objective: To assess

  1. Specificity of the FMHT in Cambodia version (CAM-FMHT) compared with the standard audiometry

  2. Likelihood ratio of the FMHT in Cambodia version (CAM-FMHT) compared with the standard audiometry

  3. Predictive value of the FMHT in Cambodia version (CAM-FMHT) compared with the standard audiometry

Study Design

Study Type:
Observational
Anticipated Enrollment :
481 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Validation Of Cambodia Version of Five Minutes Hearing Test to Screening Hearing Loss
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Nov 1, 2025

Outcome Measures

Primary Outcome Measures

  1. sensitivity of the questionnaire (FMHT in Cambodia version (CAM-FMHT)) [2 years]

    The questionnaire will be used to measure the outcome

Secondary Outcome Measures

  1. specificity of the questionnnaire (FMHT in Cambodia version (CAM-FMHT)) [2 years]

    The questionnaire will be used to measure the outcome

  2. likelihood ratio of the questionnaire (FMHT in Cambodia version (CAM-FMHT)) [2 years]

    The questionnaire will be used to measure the outcome

  3. predictive value of the questionnaire (FMHT in Cambodia version (CAM-FMHT)) [2 years]

    The questionnaire will be used to measure the outcome

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Age 18-60 years old

  • Able to read and understand Khmer language

  • Volunteer to participated

Exclusion Criteria:

  • Aphasia patients

  • Patients with severe mental disability

  • Patients with other conditions that preclude audiometry

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Khon Kaen University

Investigators

  • Principal Investigator: Dawin Rotha, M.D., Khon Kaen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dawin Rotha, MD, Principal Investigator, Khon Kaen University
ClinicalTrials.gov Identifier:
NCT05736055
Other Study ID Numbers:
  • 029NECHR
First Posted:
Feb 21, 2023
Last Update Posted:
Feb 24, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hearing Loss
Deafness

Study Results

No Results Posted as of Feb 24, 2023