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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031749
Receipt No. 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 2018/03/15

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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 Obsterics 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
Email 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
Email ykawasa@juntendo.ac.jp

Sponsor
Institute Juntendo University Graduate School of Medicine
Institute
Department

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
Email

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 Preinitiation
Date of protocol fixation
2018 Year 03 Month 19 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 19 Day
Last follow-up date
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
2018 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036158

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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