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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028899
Receipt No. R000032744
Scientific Title Influential inspection test to sleep when going to bed, which depends on presence of "AURAL SONIC panel"
Date of disclosure of the study information 2017/08/30
Last modified on 2017/12/26

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Basic information
Public title Influential inspection test to sleep when going to bed, which depends on presence of "AURAL SONIC panel"
Acronym Influential inspection test to sleep when going to bed, which depends on presence of "AURAL SONIC panel"
Scientific Title Influential inspection test to sleep when going to bed, which depends on presence of "AURAL SONIC panel"
Scientific Title:Acronym 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
1st name
Middle name
Last name Manabu Fukushima
Organization Nippon Bunri Univ
Division name Dep. of Media Technologies
Zip code
Address 1727 Ichigi, Oita city, Oita Pref., Japan
TEL 097-524-2748
Email fukushima@nbu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Manabu Fukushima
Organization Nippon Bunri Univ
Division name Dep. of Media Technologies
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Completed
Date of protocol fixation
2017 Year 08 Month 04 Day
Date of IRB
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

Other
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

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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