Thai-version Five Minute Hearing Test (Thai_FMHT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01408992|
Recruitment Status : Completed
First Posted : August 3, 2011
Results First Posted : April 16, 2014
Last Update Posted : May 5, 2014
|Condition or disease||Intervention/treatment||Phase|
|Hearing Loss||Procedure: Audiometry Other: Thai-Five Minute Hearing Test||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||558 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||The Evaluation of Thai-version Five Minute Hearing Test to Screen Hearing in Community|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||December 2011|
All community people will be interviewed with Thai Five Minute Hearing Test questionnaire and will be tested with an audiometry.
Standard hearing test performed by audiologistsOther: Thai-Five Minute Hearing Test
All subjects will be interviewed with Thai-Five Minute Hearing Test
- Standard Hearing Test [ Time Frame: 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).
- Prevalence of Ear Diseases [ Time Frame: Immediate ]the frequency of diseased ears per the total examined ears
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01408992
|Ban Phu Wang, Khon Kaen, Thailand|
|Principal Investigator:||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|