UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045222 |
|---|---|
| Receipt number | R000051659 |
| Scientific Title | The relationship between sleep quality and lifestyle during long vacations in college students |
| Date of disclosure of the study information | 2021/08/22 |
| Last modified on | 2023/01/24 12:44:11 |
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Basic information
Public title
The relationship between sleep quality and lifestyle during
long vacations in college students
Acronym
The relationship between sleep quality and lifestyle during
long vacations in college students
Scientific Title
The relationship between sleep quality and lifestyle during
long vacations in college students
Scientific Title:Acronym
The relationship between sleep quality and lifestyle during
long vacations in college students
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to interview university students about their sleep quality and lifestyle during long vacations, and to identify the activities, duration of activities, and values/interests related to sleep quality during long vacations.
Basic objectives2
Others
Basic objectives -Others
Investigating sleep quality and lifestyle
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. The Pittsburgh Sleep Quality Index Japanese Version
2. Occupational questionnaire
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 29 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Four-year college students
2. Residents of Kanto region
3. Those who have been on an extended vacation for the past month
Key exclusion criteria
1. Those who are currently undergoing treatment for sleep disorders at a medical institution
Target sample size
98
Research contact person
Name of lead principal investigator
| 1st name | Shunsuke |
| Middle name | |
| Last name | Inoue |
Organization
Tokyo Metropolitan University
Division name
Graduate School of Human Health Sciences, Department of Occupational Therapy Sciences, Pre-doctoral Program
Zip code
116-8851
Address
7-2-10, Higashiogu, Arakawa-ku, Tokyo, Japan
TEL
03-3819-1211
add.shunino@gmail.com
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Inoue |
Organization
Tokyo Metropolitan University
Division name
Graduate School of Human Health Sciences, Department of Occupational Therapy Sciences, Pre-doctoral
Zip code
116-8851
Address
7-2-10, Higashiogu, Arakawa-ku, Tokyo, Japan
TEL
03-3819-1211
Homepage URL
add.shunino@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Arakawa Campus, Tokyo Metropolitan University
Address
7-2-10, Higashiogu, Arakawa-ku, Tokyo, Japan
Tel
03-3819-1211
rinri-hs@tmu.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
東京都立大学荒川キャンパス/Tokyo Metropolitan University Arakawa Campus
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 22 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
136
Results
Comparing the two groups' perception of competence, value, and interest in daily activities, scores in competence and interest in rest-related activities were significantly lower in the poor-sleep group.
The results of multiple logistic regression analysis showed that the difference in lifestyle between the poor-sleep group and the good-sleep group was "competence in rest-related activities".
Results date posted
| 2023 | Year | 01 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The respondents were college students at four-year colleges, aged 20-29 years, living in the Kanto region, and who had been on a long vacation during the previous month.
Participant flow
The survey was conducted via an online survey system (Survey Monkey).
Adverse events
none
Outcome measures
1. The Pittsburgh Sleep Quality Index Japanese Version
2. Occupational questionnaire
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 23 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2022 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 01 | Month | 31 | Day |
Other
Other related information
To examine the relationship between sleep quality during long vacations and lifestyle factors such as activity content, activity time, and activities of value and interest among college students.
Management information
Registered date
| 2021 | Year | 08 | Month | 22 | Day |
Last modified on
| 2023 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051659
