NCT05736055

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
481

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

March 8, 2023

Status Verified

March 1, 2023

Enrollment Period

2.3 years

First QC Date

February 10, 2023

Last Update Submit

March 7, 2023

Conditions

Outcome Measures

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))

    2 years

Secondary Outcomes (3)

  • specificity of the questionnnaire (FMHT in Cambodia version (CAM-FMHT))

    2 years

  • likelihood ratio of the questionnaire (FMHT in Cambodia version (CAM-FMHT))

    2 years

  • predictive value of the questionnaire (FMHT in Cambodia version (CAM-FMHT))

    2 years

Interventions

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

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Preah Ang Duong Hospital

Phnom Penh, Cambodia

Location

MeSH Terms

Conditions

Hearing Loss

Interventions

Hearing Tests

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, OtologicalDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Dawin Rotha, M.D.

    Khon Kaen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 10, 2023

First Posted

February 21, 2023

Study Start

March 1, 2023

Primary Completion

June 1, 2025

Study Completion

November 1, 2025

Last Updated

March 8, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations