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

• Conditions: Normal Hearing; Conductive Hearing Loss, Middle Ear

• Registration Number: NCT06251817
• Lead Sponsor: Khon Kaen University

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-01
• Study First Submitted QC: 2024-02-01
• Study Start: 2024-02-05
• Study First Posted: 2024-02-09
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-24
• Last Update Posted: 2024-07-26
• Primary Completion: 2025-10-05
• Study Completion: 2026-02-26

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 290

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Normative data of wideband acoustic immittance in Thai normal hearing adults	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.)

Secondary Outcome Measures

Name	Time	Method
The wideband acoustic immittance data in Thai adults conductive hearing loss	16-18 months	The wideband acoustic immittance measures characteristic of conductive hearing loss with tympanogram types A, As, and Ad

Trial Locations

Locations (1)

Department of otolaryngology; 🇹🇭 Khon Kaen, Thailand