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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000046523
Receipt No. 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

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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
Email 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
Email tatsuya.yanagawa@shionogi.co.jp

Sponsor
Institute Shionogi & Co., Ltd.
Institute
Department

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
Email 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
URL(English) 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
Registered date File name


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