UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000044043
Receipt No. R000050289
Scientific Title Measurement of the effect of light stimulation on brain waves and daily rhythm
Date of disclosure of the study information 2021/07/01
Last modified on 2021/04/26

* 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 Measurement of the effect of light stimulation on brain waves and daily rhythm
Acronym Misasa Study
Scientific Title Measurement of the effect of light stimulation on brain waves and daily rhythm
Scientific Title:Acronym Misasa Study
Region
Japan

Condition
Condition Aging
Classification by specialty
Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the effects of light stimulation on brain waves and life rhythms in elderly people.
Basic objectives2 Others
Basic objectives -Others The aim of this study is to investigate the effects of light stimulation on circadian rhythm and sleep in elderly people.
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Measurement of changes in sleep construction before and after light stimulation in the elderly
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 light exposure for 3 hours during the daytime for 10 days.
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Elderly people over 65 years old who are hospitalized for rehabilitation
2) People who have been fully informed about the study and have given written consent of their own free will with full understanding.
Key exclusion criteria 1)People with poorly controlled cardiovascular, endocrine, cerebral, neurological or psychiatric diseases that may affect the outcome of the study.
2)People with alcohol dependence or excessive drinking habits.
3)Those with serious liver disease (AST (GOT) or ALT (GPT) of 100 U or more)
4)Those with serious renal disease (BUN > 25 mg/dL or serum creatinine > 2.0 mg/dL)
5)People with a habit of taking drugs or supplements that affect sleep
6)People with a history or family history of photosensitive seizures
7)Those who are judged by the principal investigator to be inappropriate
8)Those who have refused to give consent
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Masanori
Middle name
Last name Fujii
Organization Okayama University Hospital
Division name Department of Allergy and Respiratory Medicine
Zip code 700-8558
Address 2-5-1 Shikata-cho, Kita-ku, Okayama City, Okayama, Japan
TEL +81-86-235-7227
Email feynman8@okayama-u.ac.jp

Public contact
Name of contact person
1st name Masanori
Middle name
Last name Fujii
Organization Okayama University Hospital
Division name Department of Allergy and Respiratory Medicine
Zip code 700-8558
Address 2-5-1 Shikata-cho, Kita-ku, Okayama City, Okayama, Japan
TEL +81-86-235-7227
Homepage URL
Email feynman8@okayama-u.ac.jp

Sponsor
Institute Okayama University Hospital
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address 2-5-1 Shikata-cho, Kita-ku, Okayama City, Okayama, Japan
Tel +81-86-235-6938
Email mae6605@adm.okayama-u.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

Other administrative information
Date of disclosure of the study information
2021 Year 07 Month 01 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 Enrolling by invitation
Date of protocol fixation
2021 Year 04 Month 20 Day
Date of IRB
2021 Year 06 Month 22 Day
Anticipated trial start date
2021 Year 06 Month 22 Day
Last follow-up date
2023 Year 01 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
2021 Year 04 Month 26 Day
Last modified on
2021 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050289

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.