UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051560 |
|---|---|
| Receipt number | R000058798 |
| Scientific Title | The correlation between the reduction of short-wavelength light exposure, which inhibits bedtime melatonin production, and its effects on sleep, autonomic nervous function, stress hormones, and oxidative stress: a randomized controlled trial |
| Date of disclosure of the study information | 2023/07/09 |
| Last modified on | 2024/01/09 13:35:50 |
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Basic information
Public title
The impact of reducing specific blue light on melatonin and sleep quality: a randomized controlled trial
Acronym
The impact of reducing specific blue light on melatonin and sleep quality: a randomized controlled trial
Scientific Title
The correlation between the reduction of short-wavelength light exposure, which inhibits bedtime melatonin production, and its effects on sleep, autonomic nervous function, stress hormones, and oxidative stress: a randomized controlled trial
Scientific Title:Acronym
The correlation between the reduction of short-wavelength light exposure, which inhibits bedtime melatonin production, and its effects on sleep, autonomic nervous function, stress hormones, and oxidative stress: a randomized controlled trial
Region
| Japan |
Condition
Condition
non-functioning endocrine disease
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the relationship between melatonin, autonomic nervous function, stress hormones, oxidative stress, and the quality of sleep, determined by using glasses that selectively reduce short-wavelength light with a similar absorbance sensitivity to the photoreceptive cells (intrinsic photosensitive retinal ganglion cells: ipRGCs) involved in regulating melatonin production.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Melatonin, 6-sulphatoxymelatonin, and physical activity and autonomic nervous function during sleeping time
Key secondary outcomes
d-ROM, urine cortisol
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The glasses that selectively reduce short-wavelength light with a similar absorbance sensitivity to ipRGCs (referred to as "reducing glasses") and glasses that have minimal reduction effects but are difficult to distinguish from the reducing glasses based on appearance (referred to as "non-reducing glasses") will be transferred to our university in a randomly packaged state by Mitsui Chemicals.
Upon admission, the principal investigator or collaborator will distribute one of the packaged glasses to each participant, who will wear the glasses from 19:00 to 21:00 daily. On the first day of hospitalization and the 10th day of hospitalization, participants will wear an actigraph and an active tracer and naturally urinate before the ward lights are turned off at 21:00. The next morning, the first urine and a blood sample will be collected from the antecubital vein.
Interventions/Control_2
The glasses that selectively reduce short-wavelength light with a similar absorbance sensitivity to ipRGCs (referred to as "reducing glasses") and glasses that have minimal reduction effects but are difficult to distinguish from the reducing glasses based on appearance (referred to as "non-reducing glasses") will be transferred to our university in a randomly packaged state by Mitsui Chemicals.
Upon admission, the principal investigator or collaborator will distribute one of the packaged glasses to each participant, who will wear the glasses from 19:00 to 21:00 daily. On the first day of hospitalization and the 10th day of hospitalization, participants will wear an actigraph and an active tracer and naturally urinate before the ward lights are turned off at 21:00. The next morning, the first urine and a blood sample will be collected from the antecubital vein.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants who meet all of the following criteria will be included in the study:
1. Patients who have risk factors of atherosclerosis.
2. Individuals who have received sufficient explanations about participation in the study, have a thorough understanding, and have provided written consent voluntarily.
3. Excluding those deemed inappropriate as research subjects by the principal investigator, and all other criteria have been met.
Key exclusion criteria
Individuals who do not meet the eligibility criteria.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kanzaki |
| Middle name | |
| Last name | Akinori |
Organization
Hyogo Medical University
Division name
Diabetes, Endocrinology, and Clinical immunology
Zip code
663-8501
Address
1-1, Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL
0798-45-6473
mkadoya@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Akinori |
| Middle name | |
| Last name | Kanzaki |
Organization
Hyogo Medical University
Division name
Diabetes, Endocrinology, and Clinical immunology
Zip code
663-8501
Address
1-1, Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL
0798-45-6473
Homepage URL
akanzaki@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo Medical University
Institute
Department
Personal name
Funding Source
Organization
Mitsui Chemicals, Inc.
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
Hyogo Medical University Ethics Committee Secretariat
Address
1-1, Mukogawa-cho, Nishinomiya, Hyogo, Japan
Tel
0798-45-6066
rinri@hyo-med.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
| 2023 | Year | 07 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2023 | Year | 07 | Month | 09 | Day |
Last modified on
| 2024 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058798
