UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044185
Receipt number 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 13:08:30

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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 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 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

Value
https://center6.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