UMIN-CTR Clinical Trial

Basic information
Public title	The effect of an environmental sound with inaudible high-frequency band on acute social stress responses: A psychophysiological examination
Acronym	The effect of an environmental sound with inaudible high-frequency band on acute social stress responses: A psychophysiological examination
Scientific Title	The effect of an environmental sound with inaudible high-frequency band on acute social stress responses: A psychophysiological examination
Scientific Title:Acronym	The effect of an environmental sound with inaudible high-frequency band on acute social stress responses: A psychophysiological examination
Region	Japan

Condition
Condition	none
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to determine whether an environmental sound with high frequency band improves tolerance and enhances efficiency of recovery from social stress that experimentally induced.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	State-Trait Anxiety Inventory Stress level by visual analogue scale Heart rate(HR) Heart rate variability(HRV) Alpha-amylase in saliva
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Factorial
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	3
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	playing an environmental sound with high frequency band.
Interventions/Control_2	playing an environmental sound without high frequency band.
Interventions/Control_3	playing no sound
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <
Age-upper limit	30 years-old >
Gender	Male
Key inclusion criteria	Those who reports intact auditory and visual acuity could participate in this study. They are all 20's males and female is not supposed to be included in this study because cortisol would vary with menstrual cycle and it is difficult to control it.
Key exclusion criteria	We set exclusion criteria as follows. 1. Those who would not follow our infection prevention. 2. Those who have been COVID positive or have COVID positive housemate within 2 weeks. 3. Those who go to the hospital or take medication for the purpose of treating illnesses and injuries other than allergies. 4. Those who have or have a history of mental illness or cranial nerve illness. 5. Those who have heart / circulatory system (myocardial infarction, angina, aortic aneurysm, etc.), hyperglycemia, hypertension (or similar, upper blood pressure is 140 mmHg or higher, lower blood pressure is 90 mmHg or higher) or have a history of those. 6. Those who have or have a history of respiratory system (asthma, etc.) 7. Those who have or have f a history of digestive system (hepatitis, etc.) 8. Those who have been pointed out to have depression, hypertension, hyperglycemia, or abnormal electrocardiogram in a medical examination or a hospital examination. 9. Those who smoke habitually. 10. Those who take drugs habitually. 11. Those who consume excessive alcohol. 12. Those who are taking excessive caffeine. 13. Those who are claustrophobic or who may experience strong anxiety or fear in tight or dark spaces. 14. Those who have bleeding wounds / inflammation, blisters, or blisters on the chest or abdomen. 15. Those who are excessively obese or lean. 16. Those with diabetes, coronary heart disease, cancer, or chronic obstructive pulmonary disease. 17. Those who have a profession that involves night shifts. 18. Those who are in poor health, those who are physically unhealthy.
Target sample size	66

Research contact person
Name of lead principal investigator	1st name Hiroki Middle name Last name Moriya
Organization	Centan Inc.
Division name	Research and Development
Zip code	108-0075
Address	11F, Shinagawa East One Tower, 2-16-1, Konan, Minato city, Tokyo
TEL	03-6670-6722
Email	moriya@centan.jp

Public contact
Name of contact person	1st name Hiroki Middle name Last name Moriya
Organization	Centan Inc.
Division name	Research and Development
Zip code	108-0075
Address	11F, Shinagawa East One Tower, 2-16-1, Konan, Minato city, Tokyo
TEL	03-6670-6722
Homepage URL
Email	moriya@centan.jp

Sponsor
Institute	Centan Inc.
Institute
Department

Funding Source
Organization	MIRISE Technologies
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	Public Health Research Foundation
Address	1-1-7, Nishi-Waseda, Shinjyuku city, Tokyo
Tel	03-5287-5070
Email	rinri@phrf.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

Other administrative information
Date of disclosure of the study information	2021 Year 09 Month 11 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	Open public recruiting
Date of protocol fixation	2021 Year 08 Month 23 Day
Date of IRB	2021 Year 08 Month 18 Day
Anticipated trial start date	2021 Year 08 Month 25 Day
Last follow-up date	2021 Year 10 Month 06 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 09 Month 07 Day
Last modified on	2021 Year 09 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051807