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

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 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


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

Value
https://center6.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