UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063114 |
|---|---|
| Receipt number | R000072224 |
| Scientific Title | Assessment of Sleepiness While Driving After Night Shifts Among Shift-Working Nurses |
| Date of disclosure of the study information | 2026/10/09 |
| Last modified on | 2026/09/29 11:48:11 |
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Basic information
Public title
Sleepiness While Driving After Night Shifts in Shift-Working Nurses
Acronym
Nurse Driving Sleepiness Study
Scientific Title
Assessment of Sleepiness While Driving After Night Shifts Among Shift-Working Nurses
Scientific Title:Acronym
Nurse Driving Sleepiness Study
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate sleepiness, attentional function, and driving performance after night shifts among shift-working nurses, and to examine objective indicators that may be useful for assessing driving-related sleepiness.
Basic objectives2
Others
Basic objectives -Others
To examine the usefulness of estimated PVT performance for assessing driving risk after night shifts.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Estimated PVT performance derived from eyelid- and facial-expression-related measures obtained using non-contact monitoring
Key secondary outcomes
PERCLOS
Driving performance measures obtained using a driving simulator
Subjective measures of sleepiness and fatigue, including the Karolinska Sleepiness Scale
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Registered nurses
2. Aged 18 to <50 years
3. Commuting by car
4. Engaged in two-shift work and working at least four night shifts per month
5. Having normal vision, including corrected vision
6. Individuals who are not considered unsuitable for participation by the principal investigator
Key exclusion criteria
1. Individuals diagnosed with or receiving treatment for a sleep disorder
2. Individuals with a medical condition associated with a risk of acute deterioration or a medical history that may affect participation in the study
3. Individuals using medications that may affect sleepiness, attention, or autonomic nervous system activity, including hypnotics, anxiolytics, antidepressants, antipsychotics, antihistamines, and central nervous system stimulants
4. Individuals who are pregnant, breastfeeding, or may be pregnant
5. Individuals who are unable to complete the driving simulator task
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Abe |
Organization
University of Tsukuba
Division name
International Institute for Integrative Sleep Medicine (WPI-IIIS)
Zip code
305-0821
Address
502, COI Building, 1-2 Kasuga, Tsukuba, Ibaraki, Japan
TEL
029-859-1858
abe.takashi.gp@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Momoko |
| Middle name | |
| Last name | Kayaba |
Organization
University of Tsukuba
Division name
International Institute for Integrative Sleep Medicine (WPI-IIIS)
Zip code
305-0821
Address
502, COI Building, 1-2 Kasuga, Tsukuba, Ibaraki, Japan
TEL
029-859-1858
Homepage URL
kayaba.momoko.gb@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba Medical Ethics Committee
Address
Tennodai 1-1-1, Tsukuba, Ibaraki
Tel
029-853-3022
sien.ningenss@un.tsukuba.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
| 2026 | Year | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an observational study of shift-working nurses. Sleepiness, attentional function, and driving performance will be compared within the same participants between the post-night-shift condition and the day-off condition. The order of the two conditions will be randomized.
Management information
Registered date
| 2026 | Year | 09 | Month | 30 | Day |
Last modified on
| 2026 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072224
