Normal HearingNCT06251817
The Wideband Acoustic Immittance Data in Thai Normal Hearing and Conductive Hearing Loss Adults
An observational study of Normal Hearing and Conductive Hearing Loss, Middle Ear, run by Khon Kaen University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Hearing, Conductive Hearing Loss, Middle Ear
- How many people
- 290 participants
- Where
- 1 siteThailand
- Study dates
- 5 Feb 2024to 26 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Thai adults 18 to 59 years old who have normal hearing 245 participants and conductive hearing loss 45 participants
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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:
- What is normative data of wideband acoustic immittance in Thai normal hearing adults
- 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
- Keywords
- wideband acoustic immittance, Normal hearing, Thai adults, Conductive hearing loss, Absorbance
- Medical subject headings
- Hearing Loss, Conductive
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 3-4 months
Secondary outcomes (1)
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
Measured: 16-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start5 Feb 2024
- Primary completion5 Oct 2025 (estimated)
- Study completion26 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal HearingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Collaborators
- Prince of Songkla University, Chiang Mai University
- Responsible party
- Principal investigator, Nichtima Chayaopas, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251817
- Sponsor's protocol ID
- 67/1-2-2-1-001
- Status last verified
- Jul 2024
- First submitted
- 1 Feb 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Wideband Acoustic Immittance Data in Thai Normal Hearing and Conductive Hearing Loss Adults
- ClinicalTrials.gov ID
- NCT06251817
- Acronym / sponsor ID
- 67/1-2-2-1-001
- Keywords
- wideband acoustic immittance, Normal hearing, Thai adults, Conductive hearing loss, Absorbance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Collaborators
- Prince of Songkla University, Chiang Mai University
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 5 Oct 2025 (estimated)
- Study completion
- 26 Feb 2026 (estimated)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is normative data of wideband acoustic immittance in Thai normal hearing adults
- 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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Thai adults 18 to 59 years old who have normal hearing 245 participants and conductive hearing loss 45 participants
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.)
1 secondary outcome
The wideband acoustic immittance data in Thai adults conductive hearing loss
Time frame: 16-18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Normal Hearing and Conductive Hearing Loss, Middle Ear, run by Khon Kaen University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normative data of wideband acoustic immittance in Thai normal hearing adults (time frame: 3-4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.