UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025755
Receipt number R000029188
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 2017/01/23
Last modified on 2017/07/07 09:47:10

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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

N/A

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

65 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

11


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 or person

Institute

Nippon Bunri Univ

Institute

Department

Personal name



Funding Source

Organization

Aural Sonic, Inc.

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 01 Month 23 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

2016 Year 12 Month 21 Day

Date of IRB


Anticipated trial start date

2017 Year 01 Month 15 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 01 Month 20 Day

Last modified on

2017 Year 07 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029188


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name