Clinical trial NCT01408992: Thai-version Five Minute Hearing Test
Official title: The Evaluation of Thai-version Five Minute Hearing Test to Screen Hearing in Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Keywords: Hearing screening
Questionnaire
Hearing disability
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2011-08-03
Enrollment: 558
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

* 18 years old or older

Exclusion Criteria:

* having aphasia, or severe mental disability, or other conditions which can not accommodate audiometry.

Primary outcomes:
measure: Standard Hearing Test
timeFrame: Baseline
Secondary outcomes:
measure: Prevalence of Ear Diseases
timeFrame: Immediate
Other outcomes:
Locations:
city: Ban Phu Wang
country: Thailand
facility: Phu Weng
state: Khon Kaen
Study officials:
affiliation: Khon Kaen University
name: Kwanchanok Yimtae, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Khon Kaen University
name: Pornthep Kasemsiri, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Khon Kaen University
name: Panida Thanawirattananit, M.A.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.