UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028899 |
|---|---|
| Receipt number | 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 10:13:42 |
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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
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
fukushima@nbu.ac.jp
Sponsor or person
Institute
Nippon Bunri Univ
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032744
