The Wideband Acoustic Immittance Data in Thai Normal Hearing and Conductive Hearing Loss Adults

July 24, 2024 updated by: Nichtima Chayaopas, Khon Kaen University

The goal of this descriptive study is to collect the wideband immittance data in Thai normal hearing and conductive hearing loss adults. The main questions it aims to answer are:

  1. What is normative data of wideband acoustic immittance in Thai normal hearing adults

  2. What is the wideband acoustic immittance data in Thai conductive hearing loss who have type A, AS and Ad tympanogram Participants will examine hearing tests consequently

    • pure tone audiometry
    • Tympanometry with ipsilateral acoustic reflex
    • Wideband acoustic immittance

Study Overview

Status

Enrolling by invitation

Conditions

Study Type

Observational

Enrollment (Estimated)

290

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Khon Kaen, Thailand, 40002
        • Department of Otolaryngology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Thai adults 18 to 59 years old who have normal hearing 245 participants and conductive hearing loss 45 participants

Description

Inclusion Criteria:

Normal group

  1. Thai adults (18-60 years old)
  2. Pure-tone air-conduction thresholds ≤ 25 dB HL, measured at audiometric frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 and 8000 Hz and air-bone gab < 10 dBHL at frequencies 500, 1000, 2000 and 4000 Hz
  3. Type A tympanogram with present ipsilateral acoustic reflex
  4. No diagnosis of middle ear disease
  5. No history of middle ear surgery
  6. Normal finding in otoscopic examination

Conductive hearing loss group

  1. Thai adults (18-60 years old)
  2. Pure-tone air-conduction thresholds > 25 dB HL, measured at audiometric frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 and 8000 Hz and air-bone gab > 10 dBHL at frequencies 500, 1000, 2000 and 4000 Hz at least 2 frequencies in one ear
  3. Type A, As or Ad tympanogram with absent ipsilateral acoustic reflex
  4. Normal finding in otoscopic examination
  5. There is an appointment for exploration middle ear within 2 months

Exclusion Criteria:

  1. Have previously had middle ear surgery
  2. Have an earache
  3. Type B or C tympanogram
  4. Volunteers who do not cooperate in audiometry test or unable to do audiometry test

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Normative data of wideband acoustic immittance in Thai normal hearing adults
Time Frame: 3-4 months
Normative data of wideband acoustic immittance refers to wideband absorbance at peak pressure and wideband absorbance at ambient pressure at across frequency (226 to 8000 Hz.)
3-4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The wideband acoustic immittance data in Thai adults conductive hearing loss
Time Frame: 16-18 months
The wideband acoustic immittance measures characteristic of conductive hearing loss with tympanogram types A, As, and Ad
16-18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khon Kaen University

Collaborators

Prince of Songkla University
Chiang Mai University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2024

Primary Completion (Estimated)

October 5, 2025

Study Completion (Estimated)

February 26, 2026

Study Registration Dates

First Submitted

February 1, 2024

First Submitted That Met QC Criteria

February 1, 2024

First Posted (Actual)

February 9, 2024

Study Record Updates

Last Update Posted (Actual)

July 26, 2024

Last Update Submitted That Met QC Criteria

July 24, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 67/1-2-2-1-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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