UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062271 |
|---|---|
| Receipt number | R000071258 |
| Scientific Title | An Observational Study of Sleep Status During a Training Camp in Collegiate Athletes |
| Date of disclosure of the study information | 2026/07/17 |
| Last modified on | 2026/07/17 17:55:22 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
An Observational Study of Sleep Status During a Training Camp in Collegiate Athletes
Acronym
An Observational Study of Sleep Status During a Training Camp in Collegiate Athletes
Scientific Title
An Observational Study of Sleep Status During a Training Camp in Collegiate Athletes
Scientific Title:Acronym
An Observational Study of Sleep Status During a Training Camp in Collegiate Athletes
Region
| Japan |
Condition
Condition
N/A(healthy adults)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to clarify the characteristics of nocturnal blood glucose levels and sleep status in endurance athletes by continuously monitoring glucose concentrations during sleep and investigating their sleep status throughout a training camp.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study was to clarify the characteristics of nocturnal blood glucose levels and sleep status in endurance athletes by continuously monitoring glucose concentrations during sleep and investigating their sleep status throughout a training camp.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep quality, Nocturnal glucose levels, Training performance evaluation
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
| Not applicable |
Gender
Male
Key inclusion criteria
Healthy competitive athletes aged 18 years or older who belong to a university ekiden team.
Key exclusion criteria
1) Individuals who do not provide informed consent to participate in the study.
2) Individuals currently receiving treatment for a serious disease or medical condition.
3) Individuals unable to engage in sufficient training at the start of the study due to injury or other health conditions.
4) Individuals scheduled to undergo surgery during the study period.
5) Individuals who have been hospitalized for medical treatment within the past 6 months or are scheduled for hospitalization during the study period.
6) Individuals who regularly use prescription or over-the-counter medications during the study period.
7) Individuals currently participating in another clinical study or who have participated in a clinical study within the previous 1 month.
8) Individuals who are unable to abstain from alcohol consumption from 2 days before the start of the study until the end of the study.
9) Individuals with a habitual smoking history.
10) Individuals with irregular sleep duration and/or sleep habits.
11) Individuals currently receiving medical treatment for psychiatric disorders (e.g., depression) or sleep disorders, or those with a history of psychiatric disorders.
12) Individuals who have been diagnosed with sleep apnea syndrome or who are aware of experiencing apnea during sleep.
13) Individuals with symptoms of nocturia, or those currently receiving medical treatment and taking medication for non-urological diseases.
14) Individuals with allergies to medications and/or foods.
15) Individuals with metal allergies (including skin reactions to electrodes) or sensitive skin.
16) Individuals judged by the principal investigator to be unsuitable for participation in this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masaaki |
| Middle name | |
| Last name | Sugita |
Organization
Nippon Sport Science University
Division name
Faculty of Sport Science
Zip code
227-0033
Address
1221-1 Kamoshida-cho, Aoba-ku, Yokohama, Kanagawa 227-0033, Japan
TEL
03-5706-1148
m-sugita@nittai.ac.jp
Public contact
Name of contact person
| 1st name | Masaaki |
| Middle name | |
| Last name | Sugita |
Organization
Nippon Sport Science University
Division name
Faculty of Sport Science
Zip code
227-0033
Address
1221-1 Kamoshida-cho, Aoba-ku, Yokohama, Kanagawa 227-0033, Japan
TEL
03-5706-1148
Homepage URL
m-sugita@nittai.ac.jp
Sponsor or person
Institute
Nippon Sport Science University
Institute
Department
Personal name
Masaaki Sugita
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Sport Science University
Address
7-1-1 Fukasawa, Setagayaku, Tokyo
Tel
03-5706-0931
rinri-shinsa@nittai.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 | 07 | Month | 17 | 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 | 06 | Month | 26 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not applicable
Management information
Registered date
| 2026 | Year | 07 | Month | 17 | Day |
Last modified on
| 2026 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071258
