Tokyo, July 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062271) titled 'An Observational Study of Sleep Status During a Training Camp in Collegiate Athletes' on July 17.
Study Type:
Observational
Primary Sponsor:
Institute - Nippon Sport Science University
Condition:
Condition - N/A(healthy adults)
Classification by malignancy - Others
Genomic information - NO
Objective:
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
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 Size - 20
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071258
Disclaimer: Curated by HT Syndication.
