UMIN-ICDS Clinical Trial

Public title

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

Acronym

Sound localization test in unilateral hearing loss

Scientific Title

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

Scientific Title:Acronym

Optimal conditions and clinical utility of sound localization test in unilateral hearing loss

Region

Japan

Condition

Unilateral severe sensorineural hearing loss, unilateral severe mixed hearing loss

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Unilateral hearing loss is overwhelmingly more frequent than bilateral hearing loss, and it is difficult to talk to a large number of people or to detect both sounds from outside the field of view and approaching sounds because of poor recognition of a sound localization. The headphone method as sound localization test is ordinal, but it cannot be used under hearing aids or cochlear implants. Therefore the speaker method as sound localization test, which has not yet been standardized, is required in these conditions. In order to evaluate unilateral hearing loss, it is necessary to establish measurement conditions for sound localization test considering the impact of cranial shadow effects and cross-hearing. The purpose of this study is to explore the best measurement conditions of the speaker method to examine the clinical utilities of hearing aids by using the speaker method with/without hearing aids as a domestic multicenter collaborative research.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

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.

Key secondary outcomes

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%.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

75

years-old

>

Gender

Male and Female

Key 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.

Key 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.

Target sample size

204

Name of lead principal investigator

1st name	Takashi
Middle name
Last name	Ishino

Organization

Hiroshima University

Division name

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

Zip code

7348551

Address

1-2-3 Kasumi, Minami Ward, Hiroshima

TEL

082-257-5252

Email

tishino@hiroshima-u.ac.jp

Name of contact person

1st name	Takashi
Middle name
Last name	Ishino

Organization

Hiroshima University

Division name

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

Zip code

7358551

Address

1-2-3 Kasumi, Minami Ward, Hiroshima

TEL

082-257-5252

Homepage URL

Email

tishino@hiroshima-u.ac.jp

Institute

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

Institute

Department

Personal name

Organization

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

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Hiroshima University hospital IRB

Address

1-2-3 Kasumi, Minami Ward, Hiroshima

Tel

082-257-5596

Email

hugcp@hiroshima-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

札幌医科大学（北海道）、国際医療福祉大学病院　三田病院（東京）、慶応義塾大学（東京）、国際医療福祉大学病院（千葉）、浜松医科大学（静岡）、名古屋大学（愛知）、信州大学（長野）、神戸大学（兵庫）、山口大学（山口）、広島大学（広島）

Date of disclosure of the study information

2023

Year

04

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Open public recruiting

Date of protocol fixation

2023

Year

04

Month

07

Day

Date of IRB

2023

Year

04

Month

07

Day

Anticipated trial start date

2023

Year

04

Month

25

Day

Last follow-up date

2025

Year

06

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

2025

Year

06

Month

30

Day

Other related information

The method for recruiting the candidate
*Patients with unilateral severe hearing loss who have obtained consent at the time of medical treatment, etc., or people having healthy volunteers with normal hearing (recruited by displaying posters)

Registered date

2023

Year

04

Month

14

Day

Last modified on

2023

Year

11

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057942