UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051085 |
|---|---|
| Receipt number | R000057919 |
| Scientific Title | A study on the improvement of hearing ability in patients with unilateral hearing loss (Speech hearing threshold test by Oldenburg sentence test (OLSA)) |
| Date of disclosure of the study information | 2023/05/19 |
| Last modified on | 2023/05/17 14:00:00 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study on the improvement of hearing ability in patients with unilateral hearing loss
(Speech hearing threshold test by Oldenburg sentence test (OLSA))
Acronym
A study on the improvement of hearing ability in patients with unilateral hearing loss
(Speech hearing threshold test by Oldenburg sentence test (OLSA))
Scientific Title
A study on the improvement of hearing ability in patients with unilateral hearing loss
(Speech hearing threshold test by Oldenburg sentence test (OLSA))
Scientific Title:Acronym
A study on the improvement of hearing ability in patients with unilateral hearing loss
(Speech hearing threshold test by Oldenburg sentence test (OLSA))
Region
| Japan |
Condition
Condition
unilateral hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess binaural hearing with hearing aids in patients with unilateral hearing loss.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Effects of binaural hearing in noise
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
cross hearing aid
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with unilateral hearing loss
Healthy adult with normal hearing
Key exclusion criteria
1) Hearing-impaired patients with pathological changes in hearing ability
2) Patients who require a disease other than hearing loss that makes speech audiometry (listening to words) impossible
3) In addition, patients who are judged to be inappropriate as research subjects by the research director (co-investigator)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kazuma |
| Middle name | |
| Last name | Sugahara |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Otolaryngology
Zip code
755-8505
Address
1-1-1 Minamikogushi, Ube, Yamaguchi
TEL
0836-22-2281
kazuma@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuma |
| Middle name | |
| Last name | Sugahara |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Otolaryngology
Zip code
755-8505
Address
1-1-1 Minamikogushi, Ube, Yamaguchi
TEL
0836-22-2281
Homepage URL
kazuma@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self research funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamaguchi University Hospital
Address
1-1-1 Minamikogushi, Ube, Yamaguchi
Tel
0836-22-2428
me223@yamaguchi-u.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
国際医療福祉大学三田病院，札幌医科大学，国際医療福祉大学病院，慶応義塾大学，浜松医科大学，名古屋大学，信州大学，神戸大学，広島大学，山口大学
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 17 | Day |
Last modified on
| 2023 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057919
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
