UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031749 |
|---|---|
| Receipt number | R000036158 |
| Scientific Title | Research on the objective sleep quality in female athletes |
| Date of disclosure of the study information | 2018/03/19 |
| Last modified on | 2023/03/31 01:01:54 |
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Basic information
Public title
Research on the objective sleep quality in female athletes
Acronym
Research on the objective sleep quality in female athletes
Scientific Title
Research on the objective sleep quality in female athletes
Scientific Title:Acronym
Research on the objective sleep quality in female athletes
Region
| Japan |
Condition
Condition
poor subjective quality
Classification by specialty
| Medicine in general | Cardiology | Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess whether objective sleep quality using EEG show similar results to subjective sleep quality or not in female athletes and general women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
correlation between parameters indicated by EEG and subjective sleep quality
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
electroencephalogram/ambulatory device based on peripheral arterial tonometry
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
| 16 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
1)female athletes responding to public offerings, women without exercise habits according to public recruitment,patients who visited women's sports medicine clinic and gynecology outpatients
and
2)Patients who gave written informed consent
Key exclusion criteria
1)persons who are uneasy about the examination and can not sleep as usual
2)persons who commonly use sleeping pills
3)persons who has a disease/condition affecting sleep
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takatoshi Kasai |
Organization
Juntendo Hospital, Juntendo University School of Medcine
Division name
Cardiovascular Respiratory Sleep Medicine
Zip code
Address
2-1-1 Hongo, Bunkyoku, Tokyo, Japan
TEL
03-3813-3111
tkasai@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yu Kawasaki |
Organization
Juntendo Hospital, Juntendo University School of Medcine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
2-1-1 Hongo, Bunkyoku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
ykawasa@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japanese Center for Research on Women in Sport
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 03 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 03 | Month | 19 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 15 | Day |
Last modified on
| 2023 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036158
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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