UMIN-CTR Clinical Trial

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