UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046523 |
|---|---|
| Receipt number | R000053082 |
| Scientific Title | Effect of bright light exposure on the circadian rhythm of the elderly |
| Date of disclosure of the study information | 2022/01/10 |
| Last modified on | 2022/01/03 15:54:48 |
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Basic information
Public title
Effect of bright light exposure on the circadian rhythm of the elderly
Acronym
Effect of bright light exposure on the circadian rhythm of the elderly
Scientific Title
Effect of bright light exposure on the circadian rhythm of the elderly
Scientific Title:Acronym
Effect of bright light exposure on the circadian rhythm of the elderly
Region
| Japan |
Condition
Condition
Elderly people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the effect of bright light exposure on the circadian rhythm of the elderly in daily life.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urinary melatonin
Key secondary outcomes
1. Salivary melatonin
2. Salivary cortisol
3. Sleep parameters(sleep onset latency, sleep efficiency, total sleep time, wake after sleep onset, subjective sleep quality)
4. Volume of activity
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
2 weeks light exposure
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
| 60 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Individuals can collect the required amount of saliva (about 1.9 g) in 5 minutes
2. Individuals can understand the research contents
Key exclusion criteria
1. Individuals with SARS-CoV-2
2. Patients with insomnia or sleep apnea syndrome or restless legs syndrome
3. Patients with psychological diseases or dementia
4. Patients with severe eye diseases
5. Smokers
6. Individuals with alcohol drinking habit
7. Individuals with Long-term Care Need at levels 4 or more
8. Shift workers or night workers
9. Others who the researcher judged inappropriate
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Yanagawa |
Organization
Shionogi & Co., Ltd.
Division name
Digital Intelligence department
Zip code
541-0045
Address
1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Japan
TEL
080-2506-1404
tatsuya.yanagawa@shionogi.co.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Yanagawa |
Organization
Shionogi & Co., Ltd.
Division name
Digital Intelligence department
Zip code
541-0045
Address
1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Japan
TEL
080-2506-1404
Homepage URL
tatsuya.yanagawa@shionogi.co.jp
Sponsor or person
Institute
Shionogi & Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Shionogi & Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shionogi research IRB
Address
3-1-1, Futaba-cho, Toyonaka city, Osaka, Japan
Tel
070-7812-7654
takeshi.itoh@shionogi.co.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
| 2022 | Year | 01 | Month | 10 | 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
15
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 03 | Day |
Last modified on
| 2022 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053082
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
