UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Influential inspection test to sleep when going to bed, which depends on presence of "AURAL SONIC panel"
Title of the study (Brief title)	Influential inspection test to sleep when going to bed, which depends on presence of "AURAL SONIC panel"
Region	Japan

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

Objectives
Narrative objectives1	When going to bed, the purpose of the final examination is to inspect influence to sleep by a presence of "AURAL SONIC panel". When going to bed specifically, I have for my object to inspect sound environment in comparison of the installation presence of "AURAL SONIC panel" which is arranged articulation material.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	6-hydroxymelatonin sulfate; SaMT
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Using of AURAL SONIC panel(1day)
Interventions/Control_2	AURAL SONIC panel isn't used(1day)
Interventions/Control_3
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	[1]Japanese males and females aged 20-65 years [2]Individuals who are healthy and are not received treatment of disease [3]Individuals with the regular going to bed (turning off the lights) time and wake up time [4]Individuals whose written informed consent has been obtained [5]Individuals judged appropriate for the study by the principal
Key exclusion criteria	[1]Individuals using medical products [2]Individuals who are suspected, recived treatment of, or have a history of sleep apnea syndrome [3]Individuals who have or are suspected with the night urination, prostatomegaly, or overactive bladder [4]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease [5]Individuals with skin disease, such as atopic dermatitis [6]Individuals who have a history of hepatitis [7]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplyments in the past 3 month or will ingest those foods during the test period [8]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day) [9]Individuals who participated in other clinical studies in the past three months [10]Individuals who are or are posslibly, or are lactating [11]Individuals judged inappropriate for the study by the principal
Target sample size	10

Research contact person
Name of lead principal investigator	Manabu Fukushima
Organization	Nippon Bunri Univ
Division name	Dep. of Media Technologies
Address	1727 Ichigi, Oita city, Oita Pref., Japan
TEL	097-524-2748
Email	fukushima@nbu.ac.jp

Public contact
Name of contact person	Manabu Fukushima
Organization	Nippon Bunri Univ
Division name	Dep. of Media Technologies
Address	1727 Ichigi, Oita city, Oita Pref., Japan
TEL	097-524-2748
Homepage URL
Email	fukushima@nbu.ac.jp

Sponsor
Institute	Nippon Bunri Univ
Institute
Department

Funding Source
Organization	Tokyo kotetsu kogyo Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Anti-Aging Medical Research Center,Doshisha University
Name of secondary funｄer(s)

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	2017 Year 08 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 04 Day
Anticipated trial start date	2017 Year 08 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 08 Month 30 Day
Last modified on	2017 Year 12 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032744