UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061440 |
|---|---|
| Receipt number | R000070282 |
| Scientific Title | The impact of using a digital sleep diary on sleep quality among nursing students |
| Date of disclosure of the study information | 2026/05/01 |
| Last modified on | 2026/05/01 21:26:27 |
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Basic information
Public title
The impact of using a digital sleep diary on sleep quality among nursing students
Acronym
Digital sleep diary intervention for nursing students
Scientific Title
The impact of using a digital sleep diary on sleep quality among nursing students
Scientific Title:Acronym
Digital sleep diary intervention for nursing students
Region
| Japan |
Condition
Condition
Decreased sleep quality in nursing students
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the impact of introducing a digital sleep diary on sleep quality among nursing students.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in scores of the Pittsburgh Sleep Quality Index-Japanese Version (PSQI-J) and the Athens Insomnia Scale (AIS) at the end of the intervention (2 weeks) and at follow-up (4 weeks).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Name: Self-monitoring using a digital sleep diary
Description: During a 2-week intervention period, participants use a smartphone (Google Forms) every morning to record their previous night's sleep. The entered data is automatically aggregated and visualized, and participants receive daily feedback, including brief behavioral suggestions to promote sleep improvement.
Interventions/Control_2
Name: Usual student life (No intervention)
Description: Participants spend their usual student life without keeping a sleep diary.
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
2nd-year nursing students enrolled in a 3-year nursing vocational school, aged 18 years or older.
Those who own and can use a smartphone daily.
Those who provided informed consent to participate in this study.
Key exclusion criteria
Those who regularly take sleep medications, anti-anxiety medications, or have psychiatric disorders significantly affecting sleep.
Those with extremely irregular menstrual cycles (e.g., dysmenorrhea) or receiving hormone therapy.
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Narumi |
| Middle name | |
| Last name | Ooshige |
Organization
University of Nagasaki
Division name
Faculty of Nursing and Nutrition, Department of Nursing
Zip code
851-2195
Address
1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki
TEL
095-813-5500
mh125001@sun.ac.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Nishihara |
Organization
University of Nagasaki, Graduate School
Division name
Graduate School of Regional Design and Creation, Human Health Science major
Zip code
851-2195
Address
1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki
TEL
095-813-5500
Homepage URL
mh125001@sun.ac.jp
Sponsor or person
Institute
University of Nagasaki
Institute
Department
Personal name
Funding Source
Organization
University of Nagasaki
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, University of Nagasaki
Address
1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki
Tel
095-813-5500
mh125001@sun.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 | 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 | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 25 | 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=R000070282
