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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031314
Receipt No. R000035646
Scientific Title The effects of head cooling on sleep quality of female university students in luteal phase
Date of disclosure of the study information 2018/03/31
Last modified on 2020/03/16

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Basic information
Public title The effects of head cooling on sleep quality of female university students in luteal phase
Acronym The effects of head cooling on sleep quality in luteal phase
Scientific Title The effects of head cooling on sleep quality of female university students in luteal phase
Scientific Title:Acronym The effects of head cooling on sleep quality in luteal phase
Region
Japan

Condition
Condition Daytime sleepiness in luteal phase
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Effects of head cooling on sleep quality examined in the luteal phased women.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sleep electroencephalographic variables during head cooling
Key secondary outcomes Tympanic temperature
Subjective sleep quality

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Two nights interventions is conducted in the following order. There is wash out period(one day) between interventions.
1:Cooling
2:non cooling
3:cooling
4:non cooling

Interventions/Control_2 Two nights interventions is conducted in the following order. There is wash out period(one day) between interventions.
1:non cooling
2:Cooling
3:non cooling
4:Cooling
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
19 years-old <=
Age-upper limit
25 years-old >=
Gender Female
Key inclusion criteria 1.Female university students aged 19-25 years old.
2.Women with daytime sleepiness in luteal phase.
3.Those who joined in the explanation session and gave written informed consent.
Key exclusion criteria 1. Patient with mental disease
2. Patient with gynecological disease
3. Patient with sleep disorder
4. Patient with other severe disiese
5. Pregnant or breast-feeding women
6. Average menstrual cycle <= 24 days
7. Average menstrual cycle >= 39 days
Target sample size 14

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seiji Hamanishi
Organization Kansai university of social welfare
Division name Nursing faculty
Zip code
Address 380-3, shinden, akoshi, hyogo
TEL 0791-46-2545
Email hamanishi@kusw.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Seiji Hamanishi
Organization Kansai university of social welfare
Division name Nursing faculty
Zip code
Address 380-3, shinden, akoshi, hyogo
TEL 0791-46-2545
Homepage URL
Email hamanishi@kusw.ac.jp

Sponsor
Institute Kansai university of social waelfare, nursing faculty
Institute
Department

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
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 31 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 Completed
Date of protocol fixation
2016 Year 04 Month 01 Day
Date of IRB
2016 Year 03 Month 22 Day
Anticipated trial start date
2016 Year 05 Month 15 Day
Last follow-up date
2017 Year 11 Month 30 Day
Date of closure to data entry
2018 Year 02 Month 01 Day
Date trial data considered complete
2018 Year 02 Month 15 Day
Date analysis concluded
2018 Year 03 Month 15 Day

Other
Other related information

Management information
Registered date
2018 Year 02 Month 15 Day
Last modified on
2020 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035646

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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