UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056507 |
|---|---|
| Receipt number | R000064507 |
| Scientific Title | A Randomized Controlled Trial on Sleep Phase Shifts Induced by Light Exposure Using VR Headsets in Healthy Workers |
| Date of disclosure of the study information | 2024/12/20 |
| Last modified on | 2026/01/30 11:12:50 |
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Basic information
Public title
A Randomized Controlled Trial on Sleep Phase Shifts Induced by Light Exposure Using VR Headsets in Healthy Workers
Acronym
A Randomized Controlled Trial on Sleep Phase Shifts Induced by Light Exposure Using VR Headsets in Healthy Workers
Scientific Title
A Randomized Controlled Trial on Sleep Phase Shifts Induced by Light Exposure Using VR Headsets in Healthy Workers
Scientific Title:Acronym
A Randomized Controlled Trial on Sleep Phase Shifts Induced by Light Exposure Using VR Headsets in Healthy Workers
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to exploratorily investigate the effects of light exposure using a full-field light delivery system via a VR headset on sleep phase shifts.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The average sleep midpoint (the midpoint between bedtime and wake-up time) measured using an actigraph (KISSEI COMTEC Co., Ltd. MTN-220/MTN-221) during the screening and follow-up periods.
Key secondary outcomes
The average bedtime and wake-up time measured using an actigraph (KISSEI COMTEC Co., Ltd. MTN-220/MTN-221) during the screening and follow-up periods.
Subjective sleep evaluation based on self-reported questionnaires (average bedtime, average wake-up time, and mood upon waking).
Subjective sleep evaluation based on self-reported questionnaires (Pittsburgh Sleep Quality Index: PSQI).
Chronotype evaluation based on self-reported questionnaires (Morningness-Eveningness Questionnaire: MEQ).
Well-being evaluation based on self-reported questionnaires (Happiness Scale, Satisfaction With Life Scale: SWLS).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Intervention Name: Continuous Light Exposure
Intervention Details:
Participants will use a VR headset equipped with a research smartphone pre-installed with a light exposure application during the intervention period (Days 8 and 9). They will be exposed to continuous white light for 30 minutes per session.
Light exposure will be conducted within one hour after their habitual wake-up time, during which participants can watch a YouTube video of their choice on the central display screen.
Participants will perform the light exposure at home for two consecutive days using the provided VR headset and smartphone.
Frequency: Once daily (for 2 consecutive days)
Duration: 30 minutes per session
Interventions/Control_2
Intervention Name: Intermittent Light Exposure
Intervention Details:
During the intervention period (Days 8 and 9), participants will use a VR headset equipped with a research smartphone pre-installed with a light exposure application. They will be exposed to intermittent white light at 40 Hz (gamma frequency) along with white noise for 30 minutes per session.
Light exposure will be conducted within one hour after their habitual wake-up time, during which participants can watch a YouTube video of their choice on the central display screen.
Participants will perform the intermittent light exposure at home for two consecutive days using the provided VR headset and smartphone.
Frequency: Once daily (for 2 consecutive days)
Duration: 30 minutes per session
Interventions/Control_3
Intervention Name: Non-Exposure (Control Group)
Intervention Details:
Participants will use a VR headset equipped with a research smartphone pre-installed with a light exposure application during the intervention period (Days 8 and 9). However, no light exposure will occur (device remains off).
The application will be used within one hour after their habitual wake-up time, during which participants can watch a YouTube video of their choice on the central display screen.
Participants will perform the non-exposure intervention at home for two consecutive days using the provided VR headset and smartphone.
Frequency: Once daily (for 2 consecutive days)
Duration: 30 minutes per session
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy individuals who volunteered to participate in the study with no history of psychiatric disorders, sleep disorders, or circadian rhythm sleep-wake disorders.
2. Individuals aged 20 years or older and under 40 years at the time of obtaining consent.
3. Individuals who own a smartphone or PC and are capable of providing informed consent and electronic signatures via internet-based web conferencing.
Key exclusion criteria
1. Individuals engaged in shift work, including night shifts.
2. Individuals with color vision deficiencies or photophobia that interfere with daily life.
3. Individuals who consume alcohol regularly.
4. Individuals who regularly use psychotropic or sleep medications.5.
6. Individuals with a history or symptoms of epilepsy.
7. Individuals who have traveled across one or more time zones within three months prior to the start of the study.
8. Individuals deemed unsuitable by the principal investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Michitaka |
| Middle name | |
| Last name | Yoshimura |
Organization
Aichi Toho University
Division name
Aichi Toho University
Zip code
465-8515
Address
3-11 Heiwagaoka, meitou-ku, Nagoya, Aichi, Japan
TEL
0527-82-1724
suimin.study@gmail.com
Public contact
Name of contact person
| 1st name | Michitaka |
| Middle name | |
| Last name | Yoshimura |
Organization
Aichi Toho University
Division name
Department of Human Health
Zip code
465-8515
Address
3-11 Heiwagaoka, meitou-ku, Nagoya, Aichi, Japan
TEL
0527-82-1724
Homepage URL
suimin.study@gmail.com
Sponsor or person
Institute
Aichi Toho University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Daiko Foundation, a Public Interest Incorporated Foundation
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
shiba_palace@s-palace-clinic.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
| 2024 | Year | 12 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 10 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Methods
This study investigates changes in sleep phases following light exposure via a full-field light delivery system with a VR headset intervention compared to a non-exposure group. Participants are randomly assigned to one of three groups based on light exposure patterns continuous light exposure steady intermittent light exposure flashing or non-exposure off control. The continuous light group receives steady white light, while the intermittent group receives white light flashing at 40 Hz gamma frequency with white noise.
The study comprises a 7-day screening period to confirm eligibility and regulate daily routines, followed by a 2-day intervention period where participants use the VR headset for 30 minutes within 1 hour of waking, watching a video of their choice. A 7-day follow-up period records pre- and post-intervention sleep-wake phase shifts.
Participants wear an actigraph for 16 days, covering the screening, intervention, and follow-up periods. Daily self-reported sleep diaries and mental health assessments are also collected.
Recruitment
Participants will be recruited via SOUKEN Co Ltd. Informed consent will be obtained through a detailed information sheet.
Observational Items
A Actigraph Data Collection Day 1-16
Participants wear a compact actigraph throughout the study.
B Web-Based Questionnaires
1. Sleep and Well-being Questionnaires Day 1
Pittsburgh Sleep Quality Index
Morningness-Eveningness Questionnaire
Munich ChronoType Questionnaire
Work Limitations Questionnaire
Patient Health Questionnaire
K6 Psychological Distress Scale
Ten Item Personality Inventory
Satisfaction With Life Scale
Happiness Scale
Household and Bedroom Lighting Environment
2. Daily Morning Questionnaires Day 1-16
Sleep diary
Smartphone use before sleep
Restorative sleep quality
Sleepiness before bedtime
3. Daily Evening Questionnaires Day 1-16
Daytime mood and sleepiness
Management information
Registered date
| 2024 | Year | 12 | Month | 19 | Day |
Last modified on
| 2026 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064507
