UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047256 |
|---|---|
| Receipt number | R000053853 |
| Scientific Title | Prospective, randomized, cross-over exploratory study on the effects on melatonin concentrations in school children wearing blue light-blocking eyeglasses before bedtime |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2023/03/31 19:47:30 |
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Basic information
Public title
Study on circadian hormones in school children wearing blue light-blocking eyeglasses before bedtime
Acronym
Study on circadian hormones in school children wearing blue light-blocking eyeglasses before bedtime
Scientific Title
Prospective, randomized, cross-over exploratory study on the effects on melatonin concentrations in school children wearing blue light-blocking eyeglasses before bedtime
Scientific Title:Acronym
Prospective, randomized, cross-over exploratory study on the effects on melatonin concentrations in school children wearing blue light-blocking eyeglasses before bedtime
Region
| Japan |
Condition
Condition
Normal volunteers
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the effects of wearing blue light-blocking eyeglasses before bedtime on melatonin concentrations, sleep, and circadian rhythm in school children
Basic objectives2
Others
Basic objectives -Others
To study the effects of wearing blue light-blocking eyeglasses before bedtime on melatonin concentrations in school children
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of salivary melatonin concentration
Key secondary outcomes
1. Evaluation of circadian rhythm
2. Evaluation of sleepiness, mood, and motivation (modified NRS sleep scale)
3. Evaluation of quality and quantity of sleep (elementary school student version of the children's sleep questionnaire/chronotype evaluation)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Cross-over from blue light-blocking eyeglasses to sham eyeglasses
Interventions/Control_2
Cross-over from sham eyeglasses to blue light-blocking eyeglasses
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
| 10 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male
Key inclusion criteria
(1) Healthy male elementary school student aged 10 to 12 years at consent
(2) Regularly wears eyeglasses for correction of visual acuity in daily life
(3) Regularly exposed to an average of at least 1 hour of blue light per day from LED displays, etc., before going to bed
(4) Written informed consent obtained from the volunteer and his legal guardian prior to study participation
Key exclusion criteria
(1) Regularly wears in daily life the following lenses that cannot be prepared to the specifications of the lenses used in the study
Lenses with refractive powers outside the following range (myopia prescriptions: SPH: -8.00 to 0 D, CYL: -4.00 to 0 D, hyperopia prescriptions: SPH: 0 to +4.00 D, CYL: 0 to +4.00 D) or non-monofocal lenses such as progressive lenses and prismatic lenses
(2) The refractive power of the eyeglasses requires remeasurement in the hospital or ophthalmology department because it is realized that the refractive power of the eyeglasses regularly used in daily life is not suitable.
(3) The refractive power of the eyeglasses regularly used in daily life cannot be tested at an eyeglass store.
(4) Takes oral medications, supplements, etc., that affect sleep, the autonomic nervous system, or the central nervous system.
(5) Has previous or complicating sleep disorders, mental illness, immunologic/allergic diseases, metabolic disorders, corneal disorders, retinal disorders, dry eye, asthenopia, or the like
(6) Requires pharmacotherapy for pollinosis, etc.
(7) Has infection designated by the Infectious Disease Law or bloodborne infection (e.g., HBV, HCV, HIV, or syphilis) (including close contact with such diseases)
(8) Cannot wear correctly the testing instrument before going to bed under the guidance of a legal guardian
(9) Has irregular sleep habits
(10) Planned changes in living environment during study participation
(11) Deemed otherwise unsuitable for the study by the investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Seiji |
| Middle name | |
| Last name | Nishino |
Organization
Stanford University School of Medicine
Division name
Sleep and Circadian Neurobiology Laboratory
Zip code
CA94304
Address
3155 Porter Drive, Rm 2106 Palo Alto, CA94304, USA
TEL
650-725-8602
nishino@stanford.edu
Public contact
Name of contact person
| 1st name | Shintaro |
| Middle name | |
| Last name | Chiba |
Organization
Ota general hospital Memorial Research Institute Clinic
Division name
Ota Memorial Sleep Center
Zip code
210-0024
Address
Nisshintyo 1, Kawasaki-ku, Kawasaki-city, Kanagawa, JAPAN
TEL
044-233-5123
Homepage URL
s.chiba3387@gmail.com
Sponsor or person
Institute
Sleep and Circadian Neurobiology Laboratory, Stanford University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
JINS HOLDINGS Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Ota Memorial Sleep Center, ota general hospital Memorial Research Institute Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
ota general hospital Ethics Committee
Address
Nisshintyo 1, Kawasaki-ku, Kawasaki-city, Kanagawa, JAPAN
Tel
044-244-0131
koubai@ota-g-hospital.com
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 | 04 | 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
Completed
Date of protocol fixation
| 2022 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 07 | 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
| 2022 | Year | 03 | Month | 23 | Day |
Last modified on
| 2023 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053853
