Hearing Loss
Conditions
Keywords
Hearing disability, Hearing screening, Questionnaire
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREAudiometry
Standard hearing test performed by audiologists
OTHERThai-Five Minute Hearing Test
All subjects will be interviewed with Thai-Five Minute Hearing Test
Sponsors
Khon Kaen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years old or older
Exclusion criteria
* having aphasia, or severe mental disability, or other conditions which can not accommodate audiometry.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standard Hearing Test | Baseline | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of Ear Diseases | Immediate | the frequency of diseased ears per the total examined ears |
Countries
Thailand
Participant flow
Recruitment details
From July 2011 through September 2011, 643 Eligible persons agreed to participate. 85 persons withdrew later and 558 persons complete all study procedures.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 558 |
| Total | 558 |
Baseline characteristics
| Characteristic | Community People |
|---|---|
| Age, Customized 18-19 years | 2 participants |
| Age, Customized >,= 80 years | 17 participants |
| Age, Customized Between 20 and 29 years | 40 participants |
| Age, Customized Between 30 and 39 years | 53 participants |
| Age, Customized Between 40 and 49 years | 109 participants |
| Age, Customized Between 50 and 59 years | 128 participants |
| Age, Customized Between 60 and 69 years | 123 participants |
| Age, Customized Between 70 and 79 years | 86 participants |
| Sex: Female, Male Female | 382 Participants |
| Sex: Female, Male Male | 176 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 558 |
| serious Total, serious adverse events | 0 / 558 |
Outcome results
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).
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Normal Ears and Hearing | Standard Hearing Test | Normal Hearing | 422 participants |
| Normal Ears and Hearing | Standard Hearing Test | Mild Hearing Loss | 107 participants |
| Normal Ears and Hearing | Standard Hearing Test | Moderate Hearing Loss | 24 participants |
| Normal Ears and Hearing | Standard Hearing Test | Moderately Severe Hearing Loss | 4 participants |
| Normal Ears and Hearing | Standard Hearing Test | Severe Hearing Loss | 1 participants |
| Normal Ears and Hearing | Standard Hearing Test | Profound Hearing Loss | 0 participants |
Secondary
Prevalence of Ear Diseases
the frequency of diseased ears per the total examined ears
Time frame: Immediate
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Normal Ears and Hearing | Prevalence of Ear Diseases | 497 ears |
| Ear Wax | Prevalence of Ear Diseases | 144 ears |
| Otitis Media With Effusion | Prevalence of Ear Diseases | 3 ears |
| Chronic Otitis Media | Prevalence of Ear Diseases | 12 ears |
| Conductive Hearing Loss | Prevalence of Ear Diseases | 14 ears |
| Sensorineural Hearing Loss | Prevalence of Ear Diseases | 587 ears |
| Mixed Hearing Loss | Prevalence of Ear Diseases | 19 ears |
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.
Time frame: baseline
Population: The frequencies of subjects who had FMHT score from 0 to 45 were counted.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Normal Ears and Hearing | Sensitivity of FMHT to Detect the Hearing Loss. | 558 participants |