UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031575
Receipt No. R000035995
Scientific Title Study on healing effect of the fluctuation illumination using biomedical signal
Date of disclosure of the study information 2018/03/26
Last modified on 2020/09/07

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Study on healing effect of the fluctuation illumination using biomedical
signal
Acronym Study on healing effect of the fluctuation illumination using biomedical
signal
Scientific Title Study on healing effect of the fluctuation illumination using biomedical
signal
Scientific Title:Acronym Study on healing effect of the fluctuation illumination using biomedical
signal
Region
Japan

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

Objectives
Narrative objectives1 The aim of this study is to develop the healing LED light by using the user's biological signals.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sympathetic nerves activity(HF)
Paired comparison
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 The subjects were instructed to stare ahead while
8 lights were lit in the booth. (60min)
Interventions/Control_2
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
18 years-old <=
Age-upper limit
30 years-old >=
Gender Male and Female
Key inclusion criteria Person that informed consent was provided.
Key exclusion criteria Taking medicine affecting the autonomic system

Subjects judged by the investigator to be ineligible for other reasons
Target sample size 140

Research contact person
Name of lead principal investigator
1st name Yohei
Middle name
Last name Nomoto
Organization University of Niigata Prefecture
Division name Dept. of International Studies and Regional Development
Zip code 95008680
Address 471 Ebigase, Higashi-ku, Niigata
TEL 09061140038
Email nomoto.bil@gmail.com

Public contact
Name of contact person
1st name Yohei
Middle name
Last name Nomoto
Organization University of Niigata Prefecture
Division name Dept. of International Studies and Regional Development
Zip code 95008680
Address 471 Ebigase, Higashi-ku, Niigata
TEL 025-270-0122
Homepage URL
Email nomoto@unii.ac.jp

Sponsor
Institute University of Niigata Prefecture
Institute
Department

Funding Source
Organization University of Niigata Prefecture
Suzuka University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Suzuka University
Name of secondary funder(s)

IRB Contact (For public release)
Organization University of Niigata Prefecture
Address 471 Ebigase, Higashi-ku, Niigata
Tel 025-368-8224
Email unp@unii.ac.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 新潟県立大学(新潟県)、鈴鹿医療科学大学(三重県)

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 26 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
2018 Year 03 Month 25 Day
Date of IRB
2018 Year 03 Month 16 Day
Anticipated trial start date
2018 Year 09 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 05 Day
Last modified on
2020 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=R000035995

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.