Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is aimed to test the sensitivity and specificity of Thai-version Five Minutes Hearing test against the audiometry to screen hearing problem in community.
Study Population Phu Wieng district, Khon Kaen Province was chose to be a represent of rural community in Thailand. 551 subjects were desired to cover 80% sensitivity of the original test, at 95% confidence level, 80% power, and 7% margin of error. Regarding to 22.7% of the estimated prevalence of hearing loss and 10% drop out rate, then the total subjects need was 606 persons. Subjects were divided to recruit from simple random villages, one from the municipal and the other from non-municipal area. All people in target villages whether having ear problem or not, who was older than 18 years old, could read or understand Thai language, and wanted to participate, were persuaded. Those who had aphasia, or severe mental disability, or other conditions that could not perform audiometry were excluded.
Study Procedure After consenting to participate, subjects were interviewed with Thai-FMHT. Then the subjects were undergone the audiometry in the soundproof booth performed by audiologists who were blinded the result of Thai-FMHT. Pure tone threshold at 250, 500, 1000, 2000, 3000, 4000, 6000, 8000 Hz of both ears were recorded. Tympanogram was done to confirm middle ear pathology. Any pure tone air-conduction threshold greater than 25 dB in one or two frequencies was considered as abnormal hearing. However, the severity of hearing loss was defined by pure tone average air-conduction threshold according to ASHA criteria. To compare with the original FMHT, the pure tone average air-conduction threshold at 500, 1000, and 2000 Hz was defined as speech PTA (SF-PTA), whereas, the pure tone average air-conduction threshold at 3000, 4000, 6000, 8000 Hz was defined as high frequency PTA (HF-PTA). Hearing disability was classified according to the hearing level of the better hearing ear.
Otolaryngologists did history taking. Ear symptoms such as otalgia, itching, otorrhea, tinnitus, and hearing loss was asked before performing otoscopy and making a final diagnosis. The treatment, or medication if needed, and advice were complementary provided to subjects as post-trial benefits.
Statistical analysis Descriptive analysis was used to present demographic data. The sensitivity, specificity, and ROC were analyzed using STATA software version 10.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FMHT | Experimental | All community people will be interviewed with Thai Five Minute Hearing Test questionnaire and will be tested with an audiometry. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Audiometry | Procedure | Standard hearing test performed by audiologists |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Standard Hearing Test | Hearing loss is defined as an elevation, at least more than 25 dB of air-conduction, pure tone average threshold at speech frequencies. The severity loss is categorized into mild (26-40 dB), moderate (41-55 dB), moderately severe (56-74 dB), severe (75-90 dB), and profound (>90 dB). In this study, we aim to use FMHT as a screening tool for hearing disability (Better hearing ear has hearing threshold greater than 40 dB). | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Ear Diseases | the frequency of diseased ears per the total examined ears | Immediate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kwanchanok Yimtae, M.D. | Khon Kaen University | Principal Investigator |
| Pornthep Kasemsiri, M.D. | Khon Kaen University | Principal Investigator |
| Panida Thanawirattananit, M.A. | Khon Kaen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phu Weng | Ban Phu Wang | Changwat Khon Kaen | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24457423 | Derived | Yimtae K, Kasemsiri P, Thanawirattananit P, Siripaopradith P. Validation of the Thai five-minute hearing test to screen hearing loss in the community. Audiol Neurootol. 2014;19(2):127-34. doi: 10.1159/000357492. Epub 2014 Jan 22. |
Not provided
Not provided
A total of 551 subjects were required to obtain an 80% sensitivity rate for the original test, at a 95% confidence level, with 80% power, and a 7% margin of error. Considering 22.7% as the estimated prevalence of hearing loss [Prasansuk, 2000] and a 10% drop out rate, the total number of subjects needed was 606.
From July 2011 through September 2011, 643 Eligible persons agreed to participate. 85 persons withdrew later and 558 persons complete all study procedures.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Community People | The Phu Wieng district in Khon Kaen Province was chosen as a representative rural community in Thailand. This district comprises 114 villages and has a population of 24,201 inhabitants. Of these, 13,001 inhabitants lived in municipal areas, whereas the rest lived in non-municipal areas. The subjects were recruited from different target villages. The villages had been divided according to their municipality. The target villages were simply randomly selected from a list of villages that have more than 300 adults in their populations. One village was from a municipal area and the other village was from a non-municipal area. All of the people in the target villages, who were older than 18 years, could read or understand the Thai language, and wanted to participate, were recruited. Those who had aphasia, severe mental disability, or other conditions that precluded audiometry were excluded. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Community People | The Phu Wieng district in Khon Kaen Province was chosen as a representative rural community in Thailand. A total of 551 subjects were required to obtain an 80% sensitivity rate for the original test, at a 95% confidence level, with 80% power, and a 7% margin of error. Considering 22.7% as the estimated prevalence of hearing loss [Prasansuk, 2000] and a 10% drop out rate, the total number of subjects needed was 606. The subjects were recruited from different target villages. The villages had been divided according to their municipality. The target villages were simply randomly selected from a list of villages that have more than 300 adults in their populations. One village was from a municipal area and the other village was from a non-municipal area. All of the people in the target villages, who were older |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Prevalence of Ear Diseases | the frequency of diseased ears per the total examined ears | Posted | Number | ears | Immediate | ears | Participants |
|
6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Community People | All people who live in the Phu Wieng district in Khon Kaen Province was chosen as a representative of community people in Thailand. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kwanchanok Yimtae | Khon Kaen University | 66-43348396 | kwayim@kku.ac.th |
Not provided
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D006309 | Hearing |
| ID | Term |
|---|---|
| D000084323 | Vestibulocochlear Physiological Phenomena |
| D010829 | Physiological Phenomena |
| D012677 | Sensation |
| D009424 | Nervous System Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Thai-Five Minute Hearing Test |
| Other |
All subjects will be interviewed with Thai-Five Minute Hearing Test |
|
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG003 |
| Chronic Otitis Media |
Tympanic membrane perforation with or without ear discharge |
| OG004 | Conductive Hearing Loss | Air-bone gap and bone conduction thresholds are lower than 25 dB |
| OG005 | Sensorineural Hearing Loss | Air and bone conduction thresholds are more than 25 dB |
| OG006 | Mixed Hearing Loss | Air and bone conduction threshold are more than 25 dB with air-bone gap |
|
|
| Post-Hoc | Sensitivity of FMHT to Detect the Hearing Loss. | FMHT has 15 questions and there are 4 possible answer for each question. The best possible answer is "never" and is scored "0", "occasionally" is scored "1", "half the time" is scored "2" and "almost always" the worst answer is scored "3". The total possible range for the FMHT scores 0-45. We then compared the total score with the better hearing ears as in Outcome measure 1. The total number of participants with a score from 0 to 45, and that all participants in the study had a score within this range. It would appear, from information provided in the previous version of this record, that the total score might range from 0 to 45. | The frequencies of subjects who had FMHT score from 0 to 45 were counted. | Posted | Number | participants | baseline |
|
|
|
| Primary | Standard Hearing Test | Hearing loss is defined as an elevation, at least more than 25 dB of air-conduction, pure tone average threshold at speech frequencies. The severity loss is categorized into mild (26-40 dB), moderate (41-55 dB), moderately severe (56-74 dB), severe (75-90 dB), and profound (>90 dB). In this study, we aim to use FMHT as a screening tool for hearing disability (Better hearing ear has hearing threshold greater than 40 dB). | Posted | Number | participants | Baseline |
|
|
|
| 0 |
| 558 |
| 0 |
| 558 |
Not provided
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| Title | Measurements |
|---|---|
|
| Moderately Severe Hearing Loss |
|
| Severe Hearing Loss |
|
| Profound Hearing Loss |
|