Trial Outcomes & Findings for Thai-version Five Minute Hearing Test (NCT NCT01408992)

Last Updated: 2014-05-05

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

558 participants

Primary outcome timeframe

Baseline

Results posted on

2014-05-05

Participant Flow

From July 2011 through September 2011, 643 Eligible persons agreed to participate. 85 persons withdrew later and 558 persons complete all study procedures.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	558
Overall Study COMPLETED	558
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Thai-version Five Minute Hearing Test

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Community People n=558 Participants 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
Age, Customized 18-19 years	2 participants n=93 Participants
Age, Customized Between 20 and 29 years	40 participants n=93 Participants
Age, Customized Between 30 and 39 years	53 participants n=93 Participants
Age, Customized Between 40 and 49 years	109 participants n=93 Participants
Age, Customized Between 50 and 59 years	128 participants n=93 Participants
Age, Customized Between 60 and 69 years	123 participants n=93 Participants
Age, Customized Between 70 and 79 years	86 participants n=93 Participants
Age, Customized >,= 80 years	17 participants n=93 Participants
Sex: Female, Male Female	382 Participants n=93 Participants
Sex: Female, Male Male	176 Participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Normal Ears and Hearing n=558 Participants Normal ear examination and normal hearing	Ear Wax Impacted cerumen	Otitis Media With Effusion Fluid in middle ear, whether serous, mucoid, mucous, or pus	Chronic Otitis Media Tympanic membrane perforation with or without ear discharge	Conductive Hearing Loss Air-bone gap and bone conduction thresholds are lower than 25 dB	Sensorineural Hearing Loss Air and bone conduction thresholds are more than 25 dB	Mixed Hearing Loss Air and bone conduction threshold are more than 25 dB with air-bone gap
Standard Hearing Test Normal Hearing	422 participants	—	—	—	—	—	—
Standard Hearing Test Mild Hearing Loss	107 participants	—	—	—	—	—	—
Standard Hearing Test Moderate Hearing Loss	24 participants	—	—	—	—	—	—
Standard Hearing Test Moderately Severe Hearing Loss	4 participants	—	—	—	—	—	—
Standard Hearing Test Severe Hearing Loss	1 participants	—	—	—	—	—	—
Standard Hearing Test Profound Hearing Loss	0 participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Immediate

the frequency of diseased ears per the total examined ears

Outcome measures

Outcome measures
Measure	Normal Ears and Hearing n=1116 ears Normal ear examination and normal hearing	Ear Wax n=1116 ears Impacted cerumen	Otitis Media With Effusion n=1116 ears Fluid in middle ear, whether serous, mucoid, mucous, or pus	Chronic Otitis Media n=1116 ears Tympanic membrane perforation with or without ear discharge	Conductive Hearing Loss n=1116 ears Air-bone gap and bone conduction thresholds are lower than 25 dB	Sensorineural Hearing Loss n=1116 ears Air and bone conduction thresholds are more than 25 dB	Mixed Hearing Loss n=1116 ears Air and bone conduction threshold are more than 25 dB with air-bone gap
Prevalence of Ear Diseases	497 ears	144 ears	3 ears	12 ears	14 ears	587 ears	19 ears

POST_HOC outcome

Timeframe: baseline

Population: The frequencies of subjects who had FMHT score from 0 to 45 were counted.

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.

Outcome measures

Outcome measures
Measure	Normal Ears and Hearing n=558 Participants Normal ear examination and normal hearing	Ear Wax Impacted cerumen	Otitis Media With Effusion Fluid in middle ear, whether serous, mucoid, mucous, or pus	Chronic Otitis Media Tympanic membrane perforation with or without ear discharge	Conductive Hearing Loss Air-bone gap and bone conduction thresholds are lower than 25 dB	Sensorineural Hearing Loss Air and bone conduction thresholds are more than 25 dB	Mixed Hearing Loss Air and bone conduction threshold are more than 25 dB with air-bone gap
Sensitivity of FMHT to Detect the Hearing Loss.	558 participants	—	—	—	—	—	—

Adverse Events

Community People

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kwanchanok Yimtae

Khon Kaen University

Phone: 66-43348396

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60