UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022497 |
|---|---|
| Receipt number | R000025934 |
| Scientific Title | The relation between hearing level and influence of wearing mask |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2023/12/11 10:01:56 |
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Basic information
Public title
The relation between hearing level and influence of wearing mask
Acronym
hearing with and without mask
Scientific Title
The relation between hearing level and influence of wearing mask
Scientific Title:Acronym
hearing with and without mask
Region
| Japan |
Condition
Condition
hearing impaired
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
hearing level and influence of mask
Basic objectives2
Others
Basic objectives -Others
Influence of lip reading
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Audiology test, word recognition test with and without mask
Key secondary outcomes
questionnaire
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
with and without mask
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
normal hearing, mild hearing ~ deaf
Key exclusion criteria
The person who has difficulty in participation
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Saito |
Organization
Nara Medical University
Division name
Otolaryngology Head & Neck Surgery
Zip code
634-8522
Address
840 Shijo-cho, Kashihara-city, Nara
TEL
0744-20-3051
o-saito@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Osamu |
| Middle name | |
| Last name | Saito |
Organization
Nara Medical University
Division name
Otolaryngology Head & Neck Surgery
Zip code
634-8522
Address
840 Shijo-cho, Kashihara-city, Nara
TEL
0744-20-3051
Homepage URL
o-saito@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Nara medical university
Address
Kashihara city shijyocho840
Tel
0744223051
o-saito@naramed-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
| 2016 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
A
Publication of results
Unpublished
Result
URL related to results and publications
Audiology japan
Number of participants that the trial has enrolled
18
Results
The average of the correct answer of 50 words of normal hearing person was 49.6 when wearing a mask, 50.0 when not wearing a mask, and there was no difference in the number of correct answers depending on the presence or absence of a mask. The average of the correct answers of hearing-impaired person was 24.2 when wearing the mask, 31.4 when the mask was not worn, and a difference was found between the number of correct answers depending on the presence or absence of the mask (p <0.01).
Results date posted
| 2023 | Year | 12 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Hearing loss
Participant flow
Speech recognition with and without face mask
Adverse events
No
Outcome measures
Speech recognition score
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2016 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 27 | Day |
Last modified on
| 2023 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025934
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
