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

March 2, 2023 updated by: Dawin Rotha, MD, Khon Kaen University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

481

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The Cambodian patients complained about hearing problems. They undergo check with audiometry in Preah Ang Duong Hospital, Phanom Penh, Cambodia

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sensitivity of the questionnaire (FMHT in Cambodia version (CAM-FMHT))
Time Frame: 2 years
The questionnaire will be used to measure the outcome (score 0 (better outcome)-score45 (worse outcome))
2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khon Kaen University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2023

Primary Completion (Anticipated)

June 1, 2025

Study Completion (Anticipated)

November 1, 2025

Study Registration Dates

First Submitted

February 10, 2023

First Submitted That Met QC Criteria

February 10, 2023

First Posted (Actual)

February 21, 2023

Study Record Updates

Last Update Posted (Estimate)

March 3, 2023

Last Update Submitted That Met QC Criteria

March 2, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 029NECHR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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