UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052175 |
|---|---|
| Receipt number | R000059546 |
| Scientific Title | Research on Noise-Reduction Materials and Remote Microphone Systems for Housing and Job Assistance |
| Date of disclosure of the study information | 2023/09/30 |
| Last modified on | 2024/03/14 14:18:33 |
* 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
Research on Noise-Reduction Materials and Remote Microphone Systems for Housing and Job Assistance
Acronym
Research on Noise-Reduction Materials and Remote Microphone Systems for Housing and Job Assistance
Scientific Title
Research on Noise-Reduction Materials and Remote Microphone Systems for Housing and Job Assistance
Scientific Title:Acronym
Research on Noise-Reduction Materials and Remote Microphone Systems for Housing and Job Assistance
Region
| Japan |
Condition
Condition
Hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To support the living and employment of hearing-impaired people
Basic objectives2
Others
Basic objectives -Others
Evaluating the Effectiveness of Noise-Reducing Materials and Remote Microphone Systems
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SSQ
Key secondary outcomes
Communication ADL Test,CI-2004, Speech discrimination
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
Noise-reducing materials and remote microphone system
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
| 13 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Hearing impairment
Key exclusion criteria
Patients who cannot participate in research due to multiple disorders, etc
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Sugaya |
Organization
Okayama University Hospital
Division name
Department of Otolaryngology-Head and Neck Surgery
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
0862357307
sugaya-a@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Sugaya |
Organization
Okayama University Hospital
Division name
Department of Otolaryngology-Head and Neck Surgery
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
0862357307
Homepage URL
sugaya-a@cc.okayama-u.ac.jp
Sponsor or person
Institute
AMED
Institute
Department
Personal name
Funding Source
Organization
AMED
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
The Ethics Committee of Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, and Okayama University hospital
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
Tel
086-235-6938
mae6605@adm.okayama-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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 30 | 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 | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 08 | Month | 31 | 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
Management information
Registered date
| 2023 | Year | 09 | Month | 11 | Day |
Last modified on
| 2024 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059546
