UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000036370
Receipt No. R000041436
Scientific Title An MEG study regarding the effect of subjective air hunger using a mask on affection and cognitive function
Date of disclosure of the study information 2020/03/31
Last modified on 2020/01/16 (Ver. 12)

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Basic information
Public title An MEG study regarding the effect of subjective air hunger using a mask on affection and cognitive function
Acronym An MEG study regarding the effect of subjective air hunger using a mask on affection and cognitive function
Scientific Title An MEG study regarding the effect of subjective air hunger using a mask on affection and cognitive function
Scientific Title:Acronym An MEG study regarding the effect of subjective air hunger using a mask on affection and cognitive function
Region
Japan

Condition
Condition Healthy
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effect of the air hunger on affection and coginitve function
Basic objectives2 Others
Basic objectives -Others To investigate the neural mechanisms of air hunger
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The MEG data
Key secondary outcomes Questionnaires

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 6
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Condition 1, condition 2, condition 3
Interventions/Control_2 Condition 1, condition 3, condition 2
Interventions/Control_3 Condition 2, condition 1, condition 3
Interventions/Control_4 Condition 2, condition 3, condition 1
Interventions/Control_5 Condition 3, condition 1, condition 2
Interventions/Control_6 Condition 3, condition 2, condition 1
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
60 years-old >
Gender Male and Female
Key inclusion criteria Healthy adult
Key exclusion criteria Participants with past or current history of serious medical illness and/or brain organic disease, who take central nerve system acting drugs, who have allergic rhinitis or bronchial asthma, who are contradicted for the use of MRI, and who are judged as not suitable for participation in this study.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Masato
Middle name
Last name Uji
Organization Osaka City University Graduate School of Medicine
Division name Sports medicine
Zip code 545-8585
Address 1-4-3, Asahi-machi, Abeno-ku, Osaka, 545-8585
TEL 06-6645-3790
Email m2036283@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name Masato
Middle name
Last name Uji
Organization Osaka City University Graduate School of Medicine
Division name Sports medicine
Zip code 545-8585
Address 1-4-3, Asahi-machi, Abeno-ku, Osaka, 545-8585
TEL 06-6645-3790
Homepage URL
Email m2036283@med.osaka-cu.ac.jp

Sponsor
Institute Department of Sports Medicine, Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
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 Osaka City University Hospital Certified Review Board
Address 1-2-7, Asahi-machi, Abeno-ku, Osaka, 545-8533
Tel 06-6645-3435
Email ethics@med.osaka-cu.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 大阪市立大学医学部附属病院（大阪府）, Osaka City University Hospital (Osaka Prefecture)

Other administrative information
Date of disclosure of the study information
2020 Year 03 Month 31 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 16
Results 
While those who wear mask(group M) feel significantly subjective air hunger compared with those who do not wear mask (group C), no difference of cognitive function using reverse Stroop test is detected between group M and C.
Results date posted
2020 Year 01 Month 16 Day
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
2019 Year 02 Month 25 Day
Date of IRB
2018 Year 12 Month 27 Day
Anticipated trial start date
2020 Year 03 Month 31 Day
Last follow-up date
2020 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
2019 Year 04 Month 01 Day
Last modified on
2020 Year 01 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041436