Hearing LossCAM-FMHTNCT05736055
Validation Of Cambodia Version of Five Minutes Hearing Test
An observational study of Hearing Loss, run by Khon Kaen University at 1 site in Cambodia.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Cambodia Version Five Minutes Hearing Test
- How many people
- 481 participants
- Where
- 1 siteCambodia
- Study dates
- 1 Mar 2023to Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: The Cambodian patients complained about hearing problems. They undergo check with audiometry in Preah Ang Duong Hospital, Phanom Penh, Cambodia
Who may be able to join
- Age 18-60 years old
- Able to read and understand Khmer language
- Volunteer to participated
Who cannot join
- Aphasia patients
- Patients with severe mental disability
- Patients with other conditions that preclude audiometry
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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
- Specificity of the FMHT in Cambodia version (CAM-FMHT) compared with the standard audiometry
- Likelihood ratio of the FMHT in Cambodia version (CAM-FMHT) compared with the standard audiometry
- Predictive value of the FMHT in Cambodia version (CAM-FMHT) compared with the standard audiometry
- Conditions
- Hearing Loss
- Being tested
- Cambodia Version Five Minutes Hearing Test
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cambodia Version Five Minutes Hearing TestDiagnostic test
Also called CAM-FMHT
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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))
Measured: 2 years
Secondary outcomes (3)
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))
Measured: 2 years
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))
Measured: 2 years
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))
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Mar 2023
- Primary completionJun 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 481 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dawin Rotha, MD, Khon Kaen University
- Investigators
- Dawin Rotha, M.D., Principal investigator, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05736055
- Sponsor's protocol ID
- 029NECHR
- Acronym
- CAM-FMHT
- Status last verified
- Mar 2023
- First submitted
- 10 Feb 2023
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Of Cambodia Version of Five Minutes Hearing Test to Screening Hearing Loss
- ClinicalTrials.gov ID
- NCT05736055
- Acronym / sponsor ID
- CAM-FMHT / 029NECHR
- Conditions
- Hearing Loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 481 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Specificity of the FMHT in Cambodia version (CAM-FMHT) compared with the standard audiometry
- Likelihood ratio of the FMHT in Cambodia version (CAM-FMHT) compared with the standard audiometry
- Predictive value of the FMHT in Cambodia version (CAM-FMHT) compared with the standard audiometry
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The Cambodian patients complained about hearing problems. They undergo check with audiometry in Preah Ang Duong Hospital, Phanom Penh, Cambodia
Key inclusion criteria (3 listed)
- Age 18-60 years old
- Able to read and understand Khmer language
- Volunteer to participated
Key exclusion criteria (3 listed)
- Aphasia patients
- Patients with severe mental disability
- Patients with other conditions that preclude audiometry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cambodia Version Five Minutes Hearing TestAlso: CAM-FMHTThe 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. | Diagnostic test | – |
Primary outcome
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))
3 secondary outcomes
specificity of the questionnnaire (FMHT in Cambodia version (CAM-FMHT))
Time frame: 2 years
likelihood ratio of the questionnaire (FMHT in Cambodia version (CAM-FMHT))
Time frame: 2 years
predictive value of the questionnaire (FMHT in Cambodia version (CAM-FMHT))
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawin Rotha, M.D. principal investigator
Khon Kaen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, run by Khon Kaen University at 1 site in Cambodia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cambodia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity of the questionnaire (FMHT in Cambodia version (CAM-FMHT)) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.