NCT06251817

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:

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

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
290

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

February 5, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 9, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2026

Completed
Last Updated

July 26, 2024

Status Verified

July 1, 2024

Enrollment Period

1.7 years

First QC Date

February 1, 2024

Last Update Submit

July 24, 2024

Conditions

Keywords

wideband acoustic immittanceNormal hearingThai adultsConductive hearing lossAbsorbance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The wideband acoustic immittance data in Thai adults conductive hearing loss

    16-18 months

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Normal group
  • Thai adults (18-60 years old)
  • 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
  • Type A tympanogram with present ipsilateral acoustic reflex
  • No diagnosis of middle ear disease
  • No history of middle ear surgery
  • Normal finding in otoscopic examination
  • Conductive hearing loss group
  • Thai adults (18-60 years old)
  • 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
  • Type A, As or Ad tympanogram with absent ipsilateral acoustic reflex
  • Normal finding in otoscopic examination
  • There is an appointment for exploration middle ear within 2 months

You may not qualify if:

  • Have previously had middle ear surgery
  • Have an earache
  • Type B or C tympanogram
  • Volunteers who do not cooperate in audiometry test or unable to do audiometry test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of otolaryngology

Khon Kaen, 40002, Thailand

Location

MeSH Terms

Conditions

Hearing Loss, Conductive

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The collaborative Research Grants of CMU-KKU-PSU Cooperation Project

Study Record Dates

First Submitted

February 1, 2024

First Posted

February 9, 2024

Study Start

February 5, 2024

Primary Completion

October 5, 2025

Study Completion

February 26, 2026

Last Updated

July 26, 2024

Record last verified: 2024-07

Locations