UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the effects of applicable warming to partial body on sleep EEG
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Makoto Uchiyama
Organization	Nihon University School of Medicine
Division name	Department of Psychiatry
Address	Oyaguchi-Kamicho, Itabashi-ku, Tokyo
TEL	03-3972-8111
Email	uchiyama.makoto@nihon-u.ac.jp

Public contact
Name of contact person	Tomohisa Ichiba
Organization	Kao Corporaton
Division name	Personal Health Care Research
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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