UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031314 |
|---|---|
| Receipt number | 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 18:03:19 |
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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
| Obstetrics 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
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
hamanishi@kusw.ac.jp
Sponsor or person
Institute
Kansai university of social waelfare, nursing faculty
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035646
