UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043842
Receipt No. 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

* 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 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
Email 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
Email miyoshi.hiroaki@kao.com

Sponsor
Institute Kao Corporation
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050036

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.