UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044043 |
|---|---|
| Receipt number | 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 | 2023/10/28 09:17:25 |
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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
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
feynman8@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
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
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
| 2024 | Year | 12 | 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
| 2023 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050289
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
