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Evaluation of the effectiveness of sound localization test in unilateral hearing loss

Prospective observational study to explore the optimal conditions and clinical utility of sound localization test as an evaluation of hearing aid efficacy for unilateral hearing loss - Optimal conditions and clinical utility of sound localization test in unilateral hearing loss

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000050854
Enrollment
204
Registered
2023-04-17
Start date
2023-04-25
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Unilateral severe sensorineural hearing loss, unilateral severe mixed hearing loss

Interventions

None listed

Sponsors

Department of Otorhinolaryngology, Head and Neck Surgery, Graduate School of Biomdeical Science, Hiroshima University.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: A)Those who fall under any of the criteria of B) and meet all of the criteria of 1)and 2)are eligible. A)Unilateral highly sensorineural hearing loss or unilateral highly mixed hearing loss *The average hearing level based on standard pure tone audiometry is 70 dB or more on the affected side and 40 dB or less on the healthy side. Unilateral severe mixed hearing loss should also meet the affected bone conduction hearing level of 55 dB or less. Furthermore the average hearing level is calculated by the right.(500 Hz+1000 Hz+2000 Hz+4000 Hz)/4 B) Those who fall under the control group *The average hearing level (described above) by standard pure tone audiometry is 40 dB or less on both sides. 1)Those who are between the ages of 18 and 75 at the time of obtaining consent 2)Those who have received sufficient explanations for participation in this research, fully understood, and obtained written consent of their own free will.

Exclusion criteria

Exclusion criteria: Those who violate any of the following will not be included in this study. 1) Those with hearing loss with significant fluctuations in hearing 2) Those who have a disease other than hearing loss that makes orientation test impossible. 3) Those who are judged to be inappropriate as research subjects by the person responsible for the research.

Design outcomes

Primary

MeasureTime frame
Directional localization ability indices and various conditions for sound localization test *Calculate the direction localization ability index for each presented sound, and compare each group at a significance level (both sides) by a two-group test that takes into account age, gender, standard pure tone audiometry, morbidity period, wearing period, hearing aid wearing threshold test, pitch match/loudness balance test, and HHIA (questionnaire survey) among the background factors.

Secondary

MeasureTime frame
Association of various hearing tests results toward both directional localization ability indices and various conditions for sound localization test *Unilateral highly sensorineural hearing loss, unilateral highly mixed hearing loss, good hearing:=<30 dB HL (0.5, 1, 2, 4 kHz, respectively) & >80 dB HL (0.5, 1, 2, 4 kHz, respectively) are the secondary endpoint target groups. Directional localization ability indices are calculated for each indicated sound, and among the background factors, age, gender, standard pure tone audiometry, morbidity period, wearing period, threshold test for wearing hearing aids, pitch match/loudness balance test, and HHIA are taken into account to compare the presentation sound pressure and noise type by group at a significance level (both sides) of 5%.

Countries

Japan

Contacts

Public ContactTakashi Ishino

Hiroshima University Department of Otorhinolaryngology, Head and Neck Surgery, Graduate School of Biomdeical Science

tishino@hiroshima-u.ac.jp082-257-5252

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026