UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062609 |
|---|---|
| Receipt number | R000071668 |
| Scientific Title | An Observational Study of the Accuracy of Online Hearing Tests in People with Hearing Difficulties |
| Date of disclosure of the study information | 2026/08/18 |
| Last modified on | 2026/08/18 22:10:05 |
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Basic information
Public title
Study of the Accuracy of Online Hearing Tests in People with Hearing Difficulties
Acronym
Online Hearing Test Study
Scientific Title
An Observational Study of the Accuracy of Online Hearing Tests in People with Hearing Difficulties
Scientific Title:Acronym
R5-NHO(Sensory)-02
Region
| Japan |
Condition
Condition
Hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the equivalence of an online speech discrimination test to a hospital-based speech discrimination test in people with hearing difficulties. In addition, the study will investigate the relationship between music perception and speech discrimination by comparing the results of the online Montreal Battery of Evaluation of Amusia (MBEA) with speech discrimination test results.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Equivalence between speech discrimination scores obtained using the word list in the hospital and those obtained using the online speech discrimination test. Equivalence is defined as a 95% coverage interval for the difference between the two test results within 5%. The online hearing test will be performed within 30 days after the hospital-based assessment.
Key secondary outcomes
Association between the percentage of correct responses on the online Montreal Battery for the Evaluation of Amusia and speech discrimination scores.
Subgroup analyses of hospital-based and online speech discrimination scores according to age, hearing level, and the use of hearing aids or cochlear implants.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have undergone hearing threshold and speech discrimination tests in an otorhinolaryngology department.
Patients aged 18 years or older who have provided informed consent to participate in the study.
Key exclusion criteria
Individuals without an appropriate environment for online testing, such as those without Internet access.
Individuals considered inappropriate for participation in this study by the principal investigator or study investigators.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shujiro |
| Middle name | |
| Last name | Minami |
Organization
National Hospital Organization Tokyo Medical Center
Division name
Department of Otolaryngology
Zip code
152-8902
Address
2-5-1 Higashigaoka, Meguro-ku, Tokyo 152-8902, Japan
TEL
03-3411-0111
shujirominami@me.com
Public contact
Name of contact person
| 1st name | Shujiro |
| Middle name | |
| Last name | Minami |
Organization
National Hospital Organization Tokyo Medical Center
Division name
Department of Otolaryngology
Zip code
152-8902
Address
2-5-1 Higashigaoka, Meguro-ku, Tokyo 152-8902, Japan
TEL
03-3411-0111
Homepage URL
shujirominami@me.com
Sponsor or person
Institute
National Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Central Ethics Review Committee for Clinical Research
Address
2-5-21 Higashigaoka, Meguro-ku, Tokyo 152-8621, Japan
Tel
03-5712-5075
700-kenkyu@mail.hosp.go.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 18 | 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
199
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
Completed
Date of protocol fixation
| 2024 | Year | 02 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 12 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Non
Management information
Registered date
| 2026 | Year | 08 | Month | 18 | Day |
Last modified on
| 2026 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071668
