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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021923
Receipt No. R000025276
Scientific Title Study on the effects of applicable warming to partial body on sleep EEG
Date of disclosure of the study information 2016/04/18
Last modified on 2016/04/15

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Basic information
Public title Study on the effects of applicable warming to partial body on sleep EEG
Acronym Effects of applicable warming on sleep
Scientific Title Study on the effects of applicable warming to partial body on sleep EEG
Scientific Title:Acronym Effects of applicable 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 or cervical warming for one night on subjective sleep states and sleep EEG 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 measure on sleep quality and Objective measure on sleep EEG to the periocular or cervical warming for one night
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 No treatment
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 No-treatment-Wash out for 5 days - Treatment A - Wash out for 5 days - Treatment B
No-treatment: No treatment status is conducted more than twice for four days and examining its effects on sleep
Treatment A: Warming periocular region with a heat-generating sheet which warm the skin underneath up to 40 degree Celsius more than twice for six days and examining its effects on sleep.
Treatment B: Warming cervical region with a heat-generating sheet which warm the skin underneath up to 40 degree Celsius more than twice for six days and examining its effects on sleep.
Interventions/Control_2 Treatment A - Wash out for 5 days - Treatment B - Wash out for 5 days - No-treatment
No-treatment: No treatment status is conducted more than twice for four days and examining its effects on sleep
Treatment A: Warming periocular region with a heat-generating sheet which warm the skin underneath up to 40 degree Celsius more than twice for six days and examining its effects on sleep.
Treatment B: Warming cervical region with a heat-generating sheet which warm the skin underneath up to 40 degree Celsius more than twice for six days 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
60 years-old >
Gender Male
Key inclusion criteria Adult men who had mild sleep difficulty indicated by Pittsburgh sleep quality index score 5.5 or large but suffer from no other serious clinical sleep disorders
Key exclusion criteria History or comorbidity of major physical or mental disorders
Target sample size 10

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-ku, Tokyo
TEL 03-3972-8111
Email uchiyama.makoto@nihon-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohisa Ichiba
Organization Kao Corporaton
Division name Personal Health Care Research
Zip code
Address 2-1-3, Bunka Sumida-ku, Tokyo
TEL 03-5630-7271
Homepage URL
Email ichiba.tomohisa@kao.co.jp

Sponsor
Institute Kao Corporation
Personal Heath Care Research
Institute
Department

Funding Source
Organization Kao Corporation
Personal Health Care Research
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 04 Month 18 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
2012 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 06 Month 01 Day
Last follow-up date
2012 Year 10 Month 01 Day
Date of closure to data entry
2012 Year 12 Month 01 Day
Date trial data considered complete
2015 Year 12 Month 01 Day
Date analysis concluded
2016 Year 01 Month 23 Day

Other
Other related information

Management information
Registered date
2016 Year 04 Month 15 Day
Last modified on
2016 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025276

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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