UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061429 |
|---|---|
| Receipt number | R000070289 |
| Scientific Title | Study on Reducing the Effects of Morning Sunlight on Circadian Rhythms in Night-Shift Drivers |
| Date of disclosure of the study information | 2026/05/01 |
| Last modified on | 2026/05/01 09:23:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study on Reducing the Effects of Morning Sunlight on Circadian Rhythms in Night-Shift Drivers
Acronym
Study on Reducing the Effects of Morning Sunlight on Circadian Rhythms in Night-Shift Drivers
Scientific Title
Study on Reducing the Effects of Morning Sunlight on Circadian Rhythms in Night-Shift Drivers
Scientific Title:Acronym
Study on Reducing the Effects of Morning Sunlight on Circadian Rhythms in Night-Shift Drivers
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate whether drivers who regularly work night shifts in the transportation industry can improve their daytime sleep after returning home by wearing tinted sunglasses during driving after sunrise, compared to wearing blue light-blocking glasses. We will conduct objective sleep assessments using a simple EEG device and subjective sleep evaluations using a post-wake-up sleep questionnaire.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
For each participant, we will calculate the average values of sleep parameters (total sleep time, sleep efficiency, sleep latency, time spent awake during the night, total duration and percentage of deep sleep, etc.) on the measurement day under each condition. Using these metrics, we will conduct an exploratory analysis to determine whether daytime sleep after returning home improves when wearing tinted sunglasses while driving after sunrise, compared to when wearing blue light-blocking glasses.
Key secondary outcomes
For each participant, we will calculate the mean value of the subjective sleep assessment index obtained from the OSA-MA (Overnight Sleep Assessment-Morning) questionnaire administered upon waking on the measurement day under each condition. Using these indices, we will conduct an exploratory analysis to determine whether wearing tinted sunglasses while driving after sunrise improves subjective sleep quality during daytime sleep after returning home, compared to wearing blue light-blocking glasses.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Group A: For each participant, the study period spans 14 days, from Sunday through the following Saturday. During the first week, participants will wear tinted sunglasses from Tuesday through Saturday during periods that include driving after sunrise and driving home. For the four days from Tuesday to Friday of the first week, objective sleep assessments using an EEG device, as well as subjective sleep assessments using a pre-sleep questionnaire and a post-awakening sleep quality questionnaire, will be conducted during daytime naps after returning home. During the second week, blue light-blocking glasses will be worn under the same conditions, and the same sleep assessments will be conducted.
Interventions/Control_2
Group B: For each participant, the study period spans 14 days, from Sunday through the following Saturday. During the first week, participants will wear blue light-blocking glasses from Tuesday through Saturday during periods that include driving after sunrise and driving home. For the four days from Tuesday to Friday of the first week, objective sleep assessments using an EEG device, as well as subjective sleep assessments using a pre-sleep questionnaire and a post-wake-up sleep quality questionnaire, will be conducted for daytime naps taken after returning home. During the second week, participants will wear light-blocking sunglasses under the same conditions, and the same sleep assessments will be conducted.
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Participants must meet all of the following criteria:
1.Drivers who regularly work a five-days-on, two-days-off schedule and engage in night-shift driving work for five consecutive nights from Monday night to Friday night.
2.Individuals who can report their usual bedtime and wake-up time for each day from Sunday to Saturday, and whose calculated time in bed is not less than 5 hours.
3.Individuals who can comply with mild sleep control from the Sunday before sleep measurement until the end of sleep measurement, namely going to bed within +/-2 hours of their reported bedtime and waking up within +/-2 hours of their reported wake-up time.
4.Individuals who can avoid alcohol consumption and intake of caffeinated beverages after 4 hours before bedtime on electroencephalography measurement days.
5.Individuals who can sleep alone in a futon or bed during the study period. Sleeping in the same room with others is acceptable if each person uses independent bedding.
6.Individuals who understand the study contents and provide written informed consent voluntarily.
Key exclusion criteria
Individuals who meet any of the following criteria will be excluded:
1.Individuals currently visiting a medical institution for treatment or with a current medical history.
2.Individuals who regularly use medications, excluding vitamins.
3.Individuals who cannot discontinue supplements, foods with functional claims, health foods, or similar products related to sleep during the study period.
4.Individuals who habitually consume excessive alcohol. Excessive alcohol consumption is defined as drinking the equivalent of two go of sake or more, five times per week.
5.Individuals who are currently participating in, or planning to participate in, another clinical trial at the start of this study.
6.Individuals judged by the principal investigator to be inappropriate as study participants.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Kanbayashi |
Organization
National University Corporation University of Tsukuba
Division name
International Institute for Integrative Sleep Medicine (IIIS), University of Tsukuba
Zip code
305-0005
Address
Tennodai, Tsukuba, Ibaraki 305-8575, Japan
TEL
029-853-5857
kanbayashi.ta.fn@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Shuji |
| Middle name | |
| Last name | Nakamura |
Organization
S'UIMIN Inc.
Division name
Business Division
Zip code
1510061
Address
817 Hatsudai Center Building, 1-51-1 Hatsudai, Shibuya-ku, Tokyo 151-0061, Japan
TEL
03-6276-3662
Homepage URL
biz-cro@suimin.co.jp.jp
Sponsor or person
Institute
S'UIMIN Inc.
Institute
Department
Personal name
Funding Source
Organization
Nishikawa Yuso Co., Ltd.
Eschenbach Optik Japan 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
Medical Corporation Association Sapporo Yurinokai Hospital
Address
11-186 Yurigahara, Kita-ku, Sapporo, Hokkaido
Tel
011-771-1501
info@yurinokai.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
| 2026 | Year | 05 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 13 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 05 | Month | 01 | Day |
Last modified on
| 2026 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070289
