UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056157 |
|---|---|
| Receipt number | R000064162 |
| Scientific Title | Effects of "Sleep Rhythm Lighting" on Sleep Quality in Shift Work Nurses |
| Date of disclosure of the study information | 2024/12/20 |
| Last modified on | 2025/05/10 16:48:18 |
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Basic information
Public title
Effects of "Sleep Rhythm Lighting" on Sleep Quality in Shift Work Nurses
Acronym
Effects of "Sleep Rhythm Lighting" in Shift Work Nurses
Scientific Title
Effects of "Sleep Rhythm Lighting" on Sleep Quality in Shift Work Nurses
Scientific Title:Acronym
Effects of "Sleep Rhythm Lighting" in Shift Work Nurses
Region
| Japan |
Condition
Condition
Non-disabled person and male nurse
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether the use of "sleep rhythm lighting" is effective in improving sleep quality by regulating circadian rhythms in male nurses working shifts.
Basic objectives2
Others
Basic objectives -Others
To identify effective lifestyle habits for sleep and to derive lifestyle characteristics of people with good and poor sleep quality.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep measurement: Differences in sleep quality between intervention and control groups using Sleep Rhythm Lighting.
Lifestyle differences between groups with good and poor sleep habits according to the Pittsburgh Sleep Quality Index.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Measuring sleep before and after using "Sleep Rhythm Lighting".
Measurement period: 1 week
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male
Key inclusion criteria
Shift Work Nurses
People without sleep disorders
Key exclusion criteria
Those who are unable to understand the purpose or outline of the research in a written statement, or who are unable to answer questions.
Individuals unable to consent to research
Non-shift workers
Those who are not in the nursing profession
People with a diagnosis of a sleep disorder
People with pre-existing medical conditions that cause sleep disturbances
People taking sleeping pills or drugs or supplements that induce sleep similar to sleeping pills.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Aoishi |
Organization
Kumamoto University
Division name
Faculty of Life Science
Zip code
862-0976
Address
4-24-1, kuhonji, chuo-ku, kumamoto, kumamoto
TEL
096-373-5495
keikoao@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Aoishi |
Organization
Kumamoto Univrtsity
Division name
Faculty of Life Science
Zip code
862-0976
Address
4-24-1, kuhonji, chuo-ku, kumamoto, kumamoto
TEL
096-373-5495
Homepage URL
keikoao@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Kumamoto University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kumamoto University
Address
4-24-1, kuhonji, chuo-ku, kumamoto, kumamoto
Tel
096-373-5495
keikoao@kumamoto-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
| 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 11 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 11 | Month | 14 | Day |
Last modified on
| 2025 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064162
