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Wideband acoustic measures in Chinese ears with normal or pathological middle-ear functioning

Wideband acoustic measures in Chinese ears with normal or pathological middle-ear functioning

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800018533
Enrollment
Unknown
Registered
2018-09-05
Start date
2018-10-01
Completion date
Unknown
Last updated
2018-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Middle-ear disorder

Interventions

Population:Wideband aural acoustic transfer function, measured using wideband tympanometry. Less than one-minute objective testing in each ear once

Sponsors

Dept. of Otorhinolaryngology, Head and Neck Surgery, CUHK
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to No maximum

Inclusion criteria

Inclusion criteria: For normative data, we plan to recruit thirty participants in 1:1 gender ratio in each of the following age groups: 3 – 5;11 years, 6 – 9;11 years, 10 – 30 years, 31 – 45 years, 46 – 60 years, 61 – 75 years, 76 years old and above; corresponding to a minimum of 210 participants. The inclusion criteria are: 1. Outpatients of the Dept. of Ear, Nose and Throat of the Prince of Wales Hospital (PWH, NTEC) who are aged 3 years and above and referred to the PWH Audiology Centre for audiological assessments; 2. Negative history of chronic middle-ear disease; 3. 226 Hz tympanometric criteria within normal limits, defined as having middle-ear compliance = 0.3 ml, middle-ear pressure within +/- 100 daPa, and equivalent ear-canal volume = 2.0 cm3; 4. Absence of significant air-bone gaps in the ear to be assessed, defined as having air-bone gap of no greater than 10 dB at 0.5, 1, 2, & 4 kHz; 5. No gross eardrum abnormalities or excessive cerumen as revealed via otoscopic examination, in the ear to be assessed; 6. Able to understand the consenting procedure and willing to provide written consent; for children aged under 18 years written consent will be obtained from accompanying parent or guardian. For disease-specific data, we plan to recruit 150 adult patients meeting the following criteria: 1. Outpatients of the PWH Dept. of Ear, Nose and Throat who are aged 18 years and above and referred to the PWH Audiology Centre for audiological assessments; 2. Referral reason is middle-ear related, e.g. conductive hearing loss, otosclerosis, otitis media effusion (OME), tympanic membrane perforation, middle-ear disease; 3. Referred for standard tympanometry as well; 4. Absence of any of the exclusion criteria abovementioned for normative sample.

Exclusion criteria

Exclusion criteria: Adult or child who presents any of the followings will be excluded: active discharge in ear canal, swollen ear canal, atresia, failure to comply with test procedures including insertion of test probe.

Design outcomes

Primary

MeasureTime frame
Availability of local normative Energy Absorbance data for adult and children.;Availability of local Energy Absorbance data among ears with different middle-ear pathologies.;

Secondary

MeasureTime frame
Facilitation of clinical diagnosis and identification of certain middle ear disorders.;

Countries

China

Contacts

Public ContactProf. Michael Chi-Fai Tong

Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong

mtong@ent.cuhk.edu.hk+852 3505 1277

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026