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

Normal Hearing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06251817
• Other study ID #: 67/1-2-2-1-001
• Status: Not yet recruiting
• Start date: February 5, 2024
• Est. completion date: February 26, 2026

Study information

• Verified date: February 2024
• Source: Khon Kaen University
• Contact: Thanawan Wongkor
• Phone: +66636695950
• Email: thanawan.w[@]kkumail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 290
• Est. completion date: February 26, 2026
• Est. primary completion date: October 5, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Conductive
• Normal Hearing

Locations

Country	Name	City	State
Thailand	Department of otolaryngology	Khon Kaen

Sponsors (3)

Lead Sponsor	Collaborator
Khon Kaen University	Chiang Mai University, Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Normative data of wideband acoustic immittance in Thai normal hearing adults	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	The wideband acoustic immittance data in Thai adults conductive hearing loss	The wideband acoustic immittance measures characteristic of conductive hearing loss with tympanogram types A, As, and Ad	16-18 months