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NCT05736055 Clinical Trial

Validation Of Cambodia Version of Five Minutes Hearing Test

Hearing Loss Clinical Trial

— CAM-FMHT  

Official title:
Validation Of Cambodia Version of Five Minutes Hearing Test to Screening Hearing Loss

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05736055
Other study ID # 029NECHR
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date March 1, 2023
Est. completion date November 2025

Study information
Verified date March 2023
Source Khon Kaen University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 481
Est. completion date November 2025
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Cambodia Version Five Minutes Hearing Test
The FMHT was developed by American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS). The FMHT is composed of 15 questions. Each answer is scored as 0, 1, 2 or 3 according to the frequency of experience. If they answered 'never', the score was 0. The answer 'occasionally' scored 1, the answer 'half the time' scored 2, and the answer 'almost always' scored 3. Furthermore, it has shown more aspects, more reliability, and more assessments of the hearing impairment of the patients. 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.

Locations
Country Name City State
Cambodia Preah Ang Duong Hospital Phnom Penh

Sponsors (1)
Lead Sponsor Collaborator
Khon Kaen University

Country where clinical trial is conducted

Cambodia, 

Outcome
Type Measure Description Time frame Safety issue
Primary sensitivity of the questionnaire (FMHT in Cambodia version (CAM-FMHT)) The questionnaire will be used to measure the outcome (score 0 (better outcome)-score45 (worse outcome)) 2 years
Secondary specificity of the questionnnaire (FMHT in Cambodia version (CAM-FMHT)) The questionnaire will be used to measure the outcome (score 0 (better outcome)-score45 (worse outcome)) 2 years
Secondary likelihood ratio of the questionnaire (FMHT in Cambodia version (CAM-FMHT)) The questionnaire will be used to measure the outcome (score 0 (better outcome)-score45 (worse outcome)) 2 years
Secondary predictive value of the questionnaire (FMHT in Cambodia version (CAM-FMHT)) The questionnaire will be used to measure the outcome (score 0 (better outcome)-score45 (worse outcome)) 2 years
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