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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021007
Receipt No. R000024245
Scientific Title Study on the effect of bedtime periocular warming on sleep
Date of disclosure of the study information 2016/02/13
Last modified on 2016/03/04

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Basic information
Public title Study on the effect of bedtime periocular warming on sleep
Acronym Effects of periocular warming on sleep
Scientific Title Study on the effect of bedtime periocular warming on sleep
Scientific Title:Acronym Effects of periocular warming on sleep
Region
Japan

Condition
Condition sleep difficulty
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of periocular warming for a week on subjective sleep states in a single blind manner
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Subjective measures on sleep quality and quantity following to the periocular warming for a week
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Warming periocular region with a heat-generating sheet which warm the skin underneath it up to 40
degree Celsius and examining its effects on sleep
Interventions/Control_2 Using a sham sheet similar in appearance to the heat-generating sheet and examining its effects on sleep
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
20 years-old <=
Age-upper limit
39 years-old >=
Gender Female
Key inclusion criteria Adult women who have mild difficulty sleeping indicated by Pittsburgh sleep quality index score 5.5 or larger but suffer from no other serious clinical sleep disorders
Key exclusion criteria History or comorbidity of major physical or mental disorders
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Uchiyama
Organization Nihon University School of Medicine
Division name Department of Psychiatry
Zip code
Address Oyaguchi-Kamicho, Itabashi, Tokyo
TEL 03-3972-8111
Email uchiyama.makoto@nihon-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ichiro Nakamoto
Organization Kao Corp.
Division name Personal health care laboratory
Zip code
Address Bunka 2-1-3 Sumida, Tokyo
TEL 03-5630-7271
Homepage URL
Email sakamoto.ichioro@kao.co.jp

Sponsor
Institute Kai Corp.
Institute
Department

Funding Source
Organization Kai Corp.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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
2016 Year 02 Month 13 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
2011 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 04 Day
Last follow-up date
2011 Year 07 Month 05 Day
Date of closure to data entry
2015 Year 03 Month 31 Day
Date trial data considered complete
2015 Year 07 Month 01 Day
Date analysis concluded
2015 Year 11 Month 30 Day

Other
Other related information

Management information
Registered date
2016 Year 02 Month 13 Day
Last modified on
2016 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024245

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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