Thai-version Five Minute Hearing Test

NCT ID: NCT01408992

Last Updated: 2014-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 558 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2011-12-31

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.

Conditions

Hearing Loss

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

FMHT

All community people will be interviewed with Thai Five Minute Hearing Test questionnaire and will be tested with an audiometry.

Group Type: EXPERIMENTAL

Audiometry

Intervention Type: PROCEDURE

Standard hearing test performed by audiologists

Thai-Five Minute Hearing Test

Intervention Type: OTHER

All subjects will be interviewed with Thai-Five Minute Hearing Test

Interventions

Audiometry

Standard hearing test performed by audiologists

Intervention Type: PROCEDURE

Thai-Five Minute Hearing Test

All subjects will be interviewed with Thai-Five Minute Hearing Test

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Khon Kaen University

OTHER

Sponsor Role: lead

Responsible Party

Kwanchanok Yimtae, M.D.

Assoc. Prof. Kwanchanok Yimtae

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kwanchanok Yimtae, M.D.

Role: PRINCIPAL_INVESTIGATOR

Khon Kaen University

Pornthep Kasemsiri, M.D.

Role: PRINCIPAL_INVESTIGATOR

Khon Kaen University

Panida Thanawirattananit, M.A.

Role: PRINCIPAL_INVESTIGATOR

Khon Kaen University

Locations

Phu Weng

Ban Phu Wang, Changwat Khon Kaen, Thailand

Countries

Thailand

References

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.

Reference Type: DERIVED

PMID: 24457423 (View on PubMed)

Other Identifiers

HE541135

Identifier Type: -

Identifier Source: org_study_id