NCT01408992

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
558

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 1, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

April 16, 2014

Completed
Last Updated

May 5, 2014

Status Verified

April 1, 2014

Enrollment Period

3 months

First QC Date

August 1, 2011

Results QC Date

December 29, 2011

Last Update Submit

April 17, 2014

Conditions

Keywords

Hearing screeningQuestionnaireHearing disability

Outcome Measures

Primary Outcomes (1)

  • 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).

    Baseline

Secondary Outcomes (1)

  • Prevalence of Ear Diseases

    Immediate

Study Arms (1)

FMHT

EXPERIMENTAL

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

Procedure: AudiometryOther: Thai-Five Minute Hearing Test

Interventions

AudiometryPROCEDURE

Standard hearing test performed by audiologists

FMHT

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

FMHT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old or older

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Phu Weng

Ban Phu Wang, Changwat Khon Kaen, Thailand

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hearing Loss

Interventions

Hearing

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vestibulocochlear Physiological PhenomenaPhysiological PhenomenaSensationNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Dr. Kwanchanok Yimtae
Organization
Khon Kaen University

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Kwanchanok Yimtae

Study Record Dates

First Submitted

August 1, 2011

First Posted

August 3, 2011

Study Start

July 1, 2011

Primary Completion

October 1, 2011

Study Completion

December 1, 2011

Last Updated

May 5, 2014

Results First Posted

April 16, 2014

Record last verified: 2014-04

Locations