UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055102 |
|---|---|
| Receipt number | R000062948 |
| Scientific Title | Basic research into optimal lifestyle and sleep habits based on a survey of student athletes' sleep habits |
| Date of disclosure of the study information | 2024/07/29 |
| Last modified on | 2024/07/29 16:44:04 |
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Basic information
Public title
Basic research into optimal lifestyle and sleep habits based on a survey of student athletes' sleep habits
Acronym
Basic research into optimal lifestyle and sleep habits based on a survey of student athletes' sleep habits
Scientific Title
Basic research into optimal lifestyle and sleep habits based on a survey of student athletes' sleep habits
Scientific Title:Acronym
Basic research into optimal lifestyle and sleep habits based on a survey of student athletes' sleep habits
Region
| Japan |
Condition
Condition
actual sleep status
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to clarify the relationship between high performance in competitive sports and sleep through the following three points:
1) The relationship between sleep habits, including sleep duration and sleep time, and student athletes' lifestyle habits and subjective physical and mental symptoms
2) The detailed actual situation and dynamics of student athletes' daily sleep duration, sleep time, circadian rhythm, and other subjective physical and mental symptoms
3) To clarify the diurnal (light and dark) rhythm of sunlight due to the influence of time difference, and the optimal sleep time for maintaining and promoting brain and mental health.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The baseline survey for the 2019 academic year will consist of the selection of survey subjects, a survey of daily life conditions, and a follow-up survey. The subjects of the study will be students at Nihon University who have given their consent to participate in this study. The subjects will be 30 students who belong to the university's athlete course, are studying a wide range of competitive sports, and are expected to participate in overseas expeditions from domestic athletic organizations. The survey will be conducted without any problems, as we have already cooperated with the coaches of the competitive sports clubs to which the student athletes who are expected to participate in overseas expeditions belong. The research protocol will include a baseline survey of the daily life conditions of student athletes, as well as the following surveys on sleep habits, including sleep time and sleep time zone, lifestyle habits, and subjective physical and mental symptoms. The daily life survey will record measurements and measurements of sleep-wake patterns, physical activity, sleepiness, mood, electrocardiogram, and body temperature during daily life.
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
| 18 | years-old | <= |
Age-upper limit
| 24 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The participants are students from Nihon University who have given their consent to participate in this study. They are students belonging to the university's athlete course, studying a wide range of competitive sports, and the study will target 50 to 100 students from domestic athletic organizations who are expected to participate in overseas tours. The study will be carried out without any problems, as cooperation has already been established with the coaches of the competitive sports clubs to which the student athletes who are expected to participate in overseas tours belong. The research protocol will include a baseline survey of the student athletes' daily lives, as well as a survey of their sleep habits, including sleep duration and sleep time, lifestyle habits, and subjective physical and mental symptoms.
Key exclusion criteria
Although the subjects will be required to complete questionnaires and other procedures, there is no risk of this causing a mental burden. Although electrodes will be attached to the subjects for electrocardiograms and electroencephalographs, sufficient care will be taken to prevent health hazards such as skin disorders associated with these, and care will be taken to avoid causing a physical burden. In addition, the acceleration sensor does not cause any mental or physical burden.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Taiki |
| Middle name | |
| Last name | Komatsu |
Organization
Nihon University
Division name
College of Sports Sciences
Zip code
153-0002
Address
3-34-1, Shimouma, Setagaya-ku, Tokyo, Japan,
TEL
0364531766
komatsu.taiki@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Kayano |
| Middle name | |
| Last name | Matsushita |
Organization
Nihon University
Division name
College of Sports Sciences
Zip code
1548513
Address
3-34-1, Shimouma, Setagaya-ku, Tokyo, Japan,
TEL
0364531600
Homepage URL
matsushita.kayano@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
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
College of Sports Sciences Nihon University
Address
3-34-1, Shimouma, Setagaya-ku, Tokyo, Japan,
Tel
0364531766
rmss.kenkyu@nihon-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 | 07 | Month | 29 | Day |
Related information
URL releasing protocol
https://kaken.nii.ac.jp/ja/report/KAKENHI-PROJECT-19K11585/19K11585seika/
Publication of results
Published
Result
URL related to results and publications
https://kaken.nii.ac.jp/ja/report/KAKENHI-PROJECT-19K11585/19K11585seika/
Number of participants that the trial has enrolled
23
Results
As a result, it was inferred that the quality of sleep increases from the intensity of physical activity outside of practice, such as the time to fall asleep and the extension of the time when deep sleep (delta waves) appear (N3).
Results date posted
| 2024 | Year | 07 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The purpose of this study is to investigate the relationship between the body clock, everyday conditioning, and the improvement of athletic performance. The subjects were 23 male track and field athletes living in a dormitory. In addition to grasping the amount of physical activity and sleep state, seven of the athletes were also evaluated for sleep structure using a simple electroencephalograph. The daily student life of student athletes was evaluated by assessing the physical activity they engaged in during athletic activities and other times, and an exploratory study was conducted on activity-rest patterns related to the modulation of circadian rhythms by measuring wakefulness-sleep patterns. As a result, it was inferred that the quality of sleep increases from the intensity of physical activity outside of practice, such as the time to fall asleep and the extension of the time when deep sleep (delta waves) appear (N3).
Participant flow
The subjects were 23 male track and field club members living in a dormitory.
Adverse events
none
Outcome measures
The purpose of this study is to investigate the relationship between the body clock, everyday conditioning, and the improvement of athletic performance. The subjects were 23 male track and field athletes living in a dormitory. In addition to grasping the amount of physical activity and sleep state, seven of the athletes were also evaluated for sleep structure using a simple electroencephalograph. The daily student life of student athletes was evaluated by assessing the physical activity they engaged in during athletic activities and other times, and an exploratory study was conducted on activity-rest patterns related to the modulation of circadian rhythms by measuring wakefulness-sleep patterns. As a result, it was inferred that the quality of sleep increases from the intensity of physical activity outside of practice, such as the time to fall asleep and the extension of the time when deep sleep (delta waves) appear (N3).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study is to investigate the relationship between the body clock, everyday conditioning, and the improvement of athletic performance. The subjects were 23 male track and field athletes living in a dormitory. In addition to grasping the amount of physical activity and sleep state, seven of the athletes were also evaluated for sleep structure using a simple electroencephalograph. The daily student life of student athletes was evaluated by assessing the physical activity they engaged in during athletic activities and other times, and an exploratory study was conducted on activity-rest patterns related to the modulation of circadian rhythms by measuring wakefulness-sleep patterns. As a result, it was inferred that the quality of sleep increases from the intensity of physical activity outside of practice, such as the time to fall asleep and the extension of the time when deep sleep (delta waves) appear (N3).
Management information
Registered date
| 2024 | Year | 07 | Month | 29 | Day |
Last modified on
| 2024 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062948
