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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044185
Receipt No. R000050456
Scientific Title A study on response to the sounds (HRS001) for healthy adults
Date of disclosure of the study information 2021/05/19
Last modified on 2021/05/12

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Basic information
Public title A study on response to the sounds (HRS001) for healthy adults
Acronym A study on the response to the sounds
Scientific Title A study on response to the sounds (HRS001) for healthy adults
Scientific Title:Acronym A study on response to the sounds (HRS001) for healthy adults
Region
Japan

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

Objectives
Narrative objectives1 To explore the relaxing sounds in physical and mental
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Electroencephalography (a-wave)
Key secondary outcomes Autonomic nerve activity, amylase activity, cortisol concentration, awareness of tension and energy, subjective questionnaire about the sounds

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 Treatment
Type of intervention
Other
Interventions/Control_1 Sound1(No sound,5min)->rest(5min)->Sound2(5min)->rest(5min)->Sound3(5min)->rest(5min)->Sound4(5min)
Interventions/Control_2 Sound2(5min)->rest(5min)->Sound3(5min)->rest(5min)->Sound4(5min)->rest(5min)->Sound1(No sound,5min)
Interventions/Control_3 Sound3(5min)->rest(5min)->Sound4(5min)->rest(5min)->Sound1(No sound,5min)->rest(5min)->Sound2(5min)
Interventions/Control_4 Sound4(5min)->rest(5min)->Sound1(No sound,5min)->rest(5min)->Sound2(5min)->rest(5min)->Sound3(5min)
Interventions/Control_5 Sound2(5min)->rest(5min)->Sound1(No sound,5min)->rest(5min)->Sound3(5min)->rest(5min)->Sound4(5min)
Interventions/Control_6 Sound3(5min)->rest(5min)->Sound1(No sound,5min)->rest(5min)->Sound2(5min)->rest(5min)->Sound4(5min)
Interventions/Control_7 Sound3(5min)->rest(5min)->Sound2(5min)->rest(5min)->Sound1(No sound,5min)->rest(5min)->Sound4(5min)
Interventions/Control_8 Sound4(5min)->rest(5min)->Sound1(No sound,5min->rest(5min) ->Sound3(5min)->rest(5min)->Sound2(5min)
Interventions/Control_9 Sound4(5min)->rest(5min)->Sound2(5min)->rest(5min)->Sound1(No sound,5min)->rest(5min)->Sound3(5min)
Interventions/Control_10 Sound4(5min)->rest(5min)->Sound3(5min)->rest(5min)->Sound1(No sound,5min->rest(5min)->Sound2(5min)

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
49 years-old >=
Gender Male and Female
Key inclusion criteria Healthy males and females
Key exclusion criteria -Subjects who are hospitalized or taking medication
-Subjects with chronic health problems
-Subjects with a history of serious diseases (heart disease, kidney disease, diabetes, cancer, etc.) or subjects suffering from such diseases
- Subjects who cannot wear a heart rate monitor or electroencephalograph due to the use of a pacemaker
- Subjects who are allergic to medical tape or stickers because heart rate monitor attaches electrodes to the skin for measurement
- Subjects who suffer from rash due
to wiping off the electrode attachment area (head) with alcohol
- Subjects with hearing impairment
- Subjects who are participating in a study or clinical trial that may affect this study, such as other studies to verify the effects of relaxation
-Subjects who are deemed inappropriate as subjects of the research by the persons involved in managing the study or the study supervising physician
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Satoshi
Middle name
Last name Haramizu
Organization Kao Corporation
Division name Sensory Science Research
Zip code 131-8501
Address 2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
TEL +81-03-5630-9889
Email haramizu.satoshi@kao.com

Public contact
Name of contact person
1st name Naoya
Middle name
Last name Kitamura
Organization Kao Corporation
Division name Sensory Science Research
Zip code 131-8501
Address 2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
TEL +81-03-5630-9889
Homepage URL
Email kitamura.naoya@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 Reserach 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 19 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 09 Day
Date of IRB
2021 Year 04 Month 19 Day
Anticipated trial start date
2021 Year 05 Month 19 Day
Last follow-up date
2022 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 05 Month 12 Day
Last modified on
2021 Year 05 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050456

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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