UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043842 |
|---|---|
| Receipt number | R000050036 |
| Scientific Title | Study of the effect of face mask on conversation |
| Date of disclosure of the study information | 2021/05/01 |
| Last modified on | 2021/04/05 13:13:20 |
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Basic information
Public title
Study of the effect of face mask on conversation
Acronym
Study of the effect of face mask on conversation
Scientific Title
Study of the effect of face mask on conversation
Scientific Title:Acronym
Study of the effect of face mask on conversation
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Compare face masks with different properties (material and shape) to see if there is a difference in the sensory of conversation (speaking and listening).
Basic objectives2
Others
Basic objectives -Others
Compare face masks with different properties (material and shape) to see if there is a difference in the sensory of conversation (speaking and listening).
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensory evaluation of conversation after a single use of each face mask.
Key secondary outcomes
Measurement data of phonetics and mouth movement of the voice while using each face mask.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
10
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Project the voice via no mask > Project the voice via mask 1 > Project the voice via mask 2 > Project the voice via mask 3 > Project the voice via mask 4.
On another day, listen to the voice via no or 4 masks.
Interventions/Control_2
Project the voice via no mask > Project the voice via mask 1 > Project the voice via mask 2 > Project the voice via mask 4 > Project the voice via mask 3.
On another day, listen to the voice via no or 4 masks.
Interventions/Control_3
Project the voice via no mask > Project the voice via mask 1 > Project the voice via mask 3 > Project the voice via mask 2 > Project the voice via mask 4.
On another day, listen to the voice via no or 4 masks.
Interventions/Control_4
Project the voice via no mask > Project the voice via mask 1 > Project the voice via mask 3 > Project the voice via mask 2 > Project the voice via mask 4.
On another day, listen to the voice via no or 4 masks.
Interventions/Control_5
Project the voice via no mask > Project the voice via mask 1 > Project the voice via mask 4 > Project the voice via mask 2 > Project the voice via mask 3.
On another day, listen to the voice via no or 4 masks.
Interventions/Control_6
Project the voice via no mask > Project the voice via mask 1 > Project the voice via mask 4 > Project the voice via mask 3 > Project the voice via mask 2.
On another day, listen to the voice via no or 4 masks.
Interventions/Control_7
Project the voice via no mask > Project the voice via mask 2 > Project the voice via mask 1 > Project the voice via mask 3 > Project the voice via mask 4.
On another day, listen to the voice via no or 4 masks.
Interventions/Control_8
Project the voice via no mask > Project the voice via mask 2 > Project the voice via mask 1 > Project the voice via mask 4 > Project the voice via mask 3.
On another day, listen to the voice via no or 4 masks.
Interventions/Control_9
Project the voice via no mask > Project the voice via mask 2 > Project the voice via mask 3 > Project the voice via mask 1 > Project the voice via mask 4.
On another day, listen to the voice via no or 4 masks.
Interventions/Control_10
Project the voice via no mask > Project the voice via mask 2 > Project the voice via mask 3 > Project the voice via mask 4 > Project the voice via mask 1.
On another day, listen to the voice via no or 4 masks.
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults
Key exclusion criteria
-Subjects with unstable voice due to the effects of pollen allergy
-Those who have difficulty hearing or speaking in daily life
-Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Yamamoto |
Organization
Kao Corporation
Division name
Personal health care Lablatory
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-9416
yamamoto.shinji@kao.com
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Miyoshi |
Organization
Kao Corporation
Division name
Personal health care Lablatory
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-9416
Homepage URL
miyoshi.hiroaki@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Research Ethics Committee, Kao Corporation
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
Tel
+81-3-5630-7263
morisaki.naoko@kao.com
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
花王株式会社（東京都）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 01 | 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
| 2021 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No. of arms =24
roject the voice via no mask > Project the voice via 4 kinds of masks (4x3x2=24)
Management information
Registered date
| 2021 | Year | 04 | Month | 05 | Day |
Last modified on
| 2021 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050036
