Validation Of Cambodia Version of Five Minutes Hearing Test

• Conditions: Hearing Loss

• Registration Number: NCT05736055
• Lead Sponsor: Khon Kaen University

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.

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 Timeline

• Study First Submitted: 2023-02-10
• Study First Submitted QC: 2023-02-10
• Study First Posted: 2023-02-21
• Status Verified: 2023-03
• Study Start: 2023-03-01
• Last Update Submitted: 2023-03-07
• Last Update Posted: 2023-03-08
• Primary Completion: 2025-06
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 481

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
sensitivity of the questionnaire (FMHT in Cambodia version (CAM-FMHT))	2 years	The questionnaire will be used to measure the outcome (score 0 (better outcome)-score45 (worse outcome))

Secondary Outcome Measures

Name	Time	Method
likelihood ratio of the questionnaire (FMHT in Cambodia version (CAM-FMHT))	2 years	The questionnaire will be used to measure the outcome (score 0 (better outcome)-score45 (worse outcome))
predictive value of the questionnaire (FMHT in Cambodia version (CAM-FMHT))	2 years	The questionnaire will be used to measure the outcome (score 0 (better outcome)-score45 (worse outcome))
specificity of the questionnnaire (FMHT in Cambodia version (CAM-FMHT))	2 years	The questionnaire will be used to measure the outcome (score 0 (better outcome)-score45 (worse outcome))

Trial Locations

Locations (1)

Preah Ang Duong Hospital; 🇰🇭 Phnom Penh, Cambodia