CClinicalTrials.gg
Enrolling by invitationNCT05736055CAM-FMHTUpdated Mar 8, 2023

Validation Of Cambodia Version of Five Minutes Hearing Test

An observational study in Hearing Loss, sponsored by Khon Kaen University. Enrolling by invitation at 1 site in Cambodia. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-03-08.

Sponsored by Khon Kaen University · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
481
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Hearing Loss
03

In context

Hearing Loss

1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.

This study's planned enrollment of 481 is above the median of 87 across 270 observational studies indexed under Hearing Loss.

Browse Hearing Loss studies →

Lead sponsor

Khon Kaen University is the lead sponsor of 160 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

Inclusion criteria

  • Age 18-60 years old
  • Able to read and understand Khmer language
  • Volunteer to participated

Exclusion criteria

Exclusion Criteria:

  • Aphasia patients
  • Patients with severe mental disability
  • Patients with other conditions that preclude audiometry
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
481 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testCambodia 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.

    Also known as: CAM-FMHT

06

What researchers measure

Primary outcomes

  1. 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))

    Time frame: 2 years

Secondary outcomes

  1. 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))

    Time frame: 2 years

  2. 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))

    Time frame: 2 years

  3. 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))

    Time frame: 2 years

07

Study locations

1 site
  • Preah Ang Duong Hospital
    Phnom Penh, Cambodia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05736055
Lead sponsor
Khon Kaen University
Responsible party
Dawin Rotha, MD (Principal Investigator, Khon Kaen University) — Principal investigator
First posted
Feb 21, 2023
Start date
Mar 1, 2023
Primary completion
Jun 2025 (estimated)
Completion
Nov 2025 (estimated)
Last update
Mar 8, 2023

Study contacts

Dawin Rotha, M.D.
principal investigator · Khon Kaen University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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