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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name