UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056718 |
|---|---|
| Receipt number | R000064441 |
| Scientific Title | Examining the Effects of Doctors' Night Shifts on Sleep |
| Date of disclosure of the study information | 2025/01/30 |
| Last modified on | 2026/01/15 10:41:39 |
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Basic information
Public title
Examining the Effects of Doctors' Night Shifts on Sleep
Acronym
Examining the Effects of Doctors' Night Shifts on Sleep
Scientific Title
Examining the Effects of Doctors' Night Shifts on Sleep
Scientific Title:Acronym
Examining the Effects of Doctors' Night Shifts on Sleep
Region
| Japan |
Condition
Condition
Sleep disorders
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of night shifts on sleep EEG patterns in medical residents.
Basic objectives2
Others
Basic objectives -Others
To investigate the effects of night shifts on sleep EEG patterns in medical residents.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The difference in the duration of non-REM sleep stage 3 measured by sleep EEG between nighttime sleep following daytime work and nighttime sleep following a night shift.
Key secondary outcomes
The difference in sleep onset latency measured by sleep EEG between nighttime sleep following daytime work and nighttime sleep following a night shift.
The correlation between sleep EEG parameters and subjective sleep restoration the following morning.
The correlation between sleep EEG parameters and the LF/HF ratio the following morning.
The correlation between sleep EEG parameters and the urinary cortisol-to-creatinine ratio the following morning.
The correlation between sleep EEG parameters and the postprandial glucose incremental area under the curve (iAUC) the following morning.
The difference in subjective sleep restoration between waking after a day shift and waking after a night shift.
The difference in the LF/HF ratio between waking after a day shift and waking after a night shift.
The difference in the urinary cortisol-to-creatinine ratio between waking after a day shift and waking after a night shift.
The difference in the postprandial glucose incremental area under the curve (iAUC) between waking after a day shift and waking after a night shift.
The correlation between the standard deviation of nighttime sleep duration, as measured by actigraphy, and both the average glucose levels and the standard deviation of glucose levels during the observation period.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Medical residents at Kyoto University Hospital who are engaged in night shifts at the emergency outpatient department.
Key exclusion criteria
Individuals taking hypnotics or sleep-improving medications.
Individuals receiving treatment for arrhythmia, myocardial infarction, or heart failure.
Individuals diagnosed with hypertension, sleep apnea syndrome, diabetes mellitus, or dyslipidemia.
Individuals on continuous oral or intravenous steroid therapy.
Individuals receiving treatment for liver, kidney, or pancreatic diseases.
Individuals with severe underweight, defined as a BMI less than 16 kilograms per square meter, or severe obesity, defined as a BMI of 35 kilograms per square meter or greater.
Smokers.
Individuals with a history of international travel within two weeks prior to the start of observation.
Individuals with allergies to wheat, eggs, milk components, soy, or oranges.
Any individual deemed unsuitable for participation in this study by the principal investigator or sub-investigators.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Kaori |
| Middle name | |
| Last name | Ikeda |
Organization
Kyoto University Hospital
Division name
Institute for Advancement of Clinical and Translational Science
Zip code
606-8507
Address
54 Kawaramachi, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
075-751-4639
krikeda@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Aki |
| Middle name | |
| Last name | Kondo |
Organization
Kyoto University Hospital
Division name
Clinical Genetics Unit
Zip code
606-8507
Address
54 Kawaramachi, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
075-751-3560
Homepage URL
akondo@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Kaori Ikeda
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto, Japan
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
| 2025 | Year | 01 | Month | 30 | 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
15
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
| 2024 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1) Study Design: Observational study, prospective, cross-sectional study, descriptive epidemiological study
2) Recruitment Method: Study participants will be recruited from among the medical residents at Kyoto University Hospital. Recruitment posters will be displayed within the hospital to invite participation.
Management information
Registered date
| 2025 | Year | 01 | Month | 14 | Day |
Last modified on
| 2026 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064441
