UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051360 |
|---|---|
| Receipt number | R000058597 |
| Scientific Title | Exploring the optimal condition of speech-in-noise testing for unilateral and asymmetric hearing loss. |
| Date of disclosure of the study information | 2023/06/19 |
| Last modified on | 2023/06/16 15:05:39 |
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Basic information
Public title
Evaluation of the effectiveness of speech-in-noise testing in unilateral hearing loss
Acronym
speech-in-noise testing in unilateral hearing loss
Scientific Title
Exploring the optimal condition of speech-in-noise testing for unilateral and asymmetric hearing loss.
Scientific Title:Acronym
Exploring the optimal condition of speech-in-noise testing for unilateral hearing loss.
Region
| Japan |
Condition
Condition
Unilateral severe sensorineural hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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. In order to evaluate unilateral hearing loss, it is necessary to establish measurement conditions for speech-in-noise test considering the impact of cranial shadow effects and cross-hearing. The purpose of this study is to explore the best measurement conditions of speech-in-noise test to examine the clinical utilities of hearing aids by using 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
Assessment
Primary outcomes
Speech perception in silence and for each signal-to-noise ratio.
Key secondary outcomes
Differences in speech perception by monosyllable or word
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those who fall under any of the criteria of A) or 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.
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
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
120
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Yamada |
Organization
International University of Health and Welfare Hospital
Division name
Otorhinolaryngology
Zip code
329-2763
Address
537-3 Iguchi Nasushiobara city, Tochigi
TEL
0287-37-2221
y-yamada@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Tono |
Organization
International University of Health and Welfare Hospital
Division name
Otorhinolaryngology
Zip code
329-2763
Address
537-3 Iguchi Nasushiobara city, Tochigi
TEL
0287-37-2221
Homepage URL
tono@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of education, culture, sports, science and technology-Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare IRB
Address
537-3 Iguchi Nasushiobara city, Tochigi
Tel
0287-37-2221
y-yamada@iuhw.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
札幌医科大学（北海道）、国際医療福祉大学病院（栃木）、国際医療福祉大学三田病院（東京）、慶応義塾大学（東京）、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）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 06 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 06 | Month | 30 | 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
| 2023 | Year | 06 | Month | 30 | Day |
Other
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 or people having healthy volunteers with normal hearing.
Management information
Registered date
| 2023 | Year | 06 | Month | 16 | Day |
Last modified on
| 2023 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058597
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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