UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A single-blind crossover study examining the influence which warming and humidification to a throat nose exert on sleep or a nose throat state with healthy adult
Title of the study (Brief title)	Research of influence which warming and humidification to a throat nose exert on sleep or a nose throat state
Region	Japan

Condition
Condition	Sleep difficulty
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Warming and humidification to a throat nose evaluate sleep and the influence of the state on a throat nose.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Subjective measurement for sleep quality and objective measurement for actimeter
Key secondary outcomes	Subjective measurement for a state of nose and throat, relaxed feeling, and anxiety

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Treatment A (2 weeks) ->Wash out (1 week)->Treatment B (2 weeks) Treatment A: Appling a moisture rich mask for 15min. before bedtime. Treatment B: Appling a moisture poor mask for 15 min. before bedtime.
Interventions/Control_2	Treatment B (2 weeks) ->Wash out (1 week)->Treatment A (2 weeks) Treatment A: Appling a moisture rich mask for 15min. before bedtime. Treatment B: Appling a moisture poor mask for 15 min. before bedtime.
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 and Female
Key inclusion criteria	1)Subjects have a trouble to a throat nose in winter 2)Subjects indicate by Pittsburgh sleep quality index score in the range of 6 to 12
Key exclusion criteria	1) Subjects who have dermatological disorders around their mouth and nose. 2) Subjects who appear eczema by contact of warm temperature or a nonwoven fabric 3) Subjects who fall thermesthesia or sensitive to temperature 4) Subjects who are undergoing the medical practitioner's therapy 5) Subjects who have an interruption in the circulation of diabetes mellitus 6) Feel dizzy easily 7) Subjects who have caused the allergy disease 8) <female> Subjects under pregnancy or with a possibility of having become pregnant 9) Subjects who feel worsens by a scent 10) Smorker 11) Subjects who are using the sleeping drug
Target sample size	30

Research contact person
Name of lead principal investigator	Ikuo Homma
Organization	Tokyo Ariake University of Medical and Health Science
Division name	Faculty of Health Science
Address	2-9-1 Ariake, Koto-ku, Tokyo
TEL	03-6703-7011
Email	hommai@tau.ac.jp

Public contact
Name of contact person	Shigemi Tsuchiya
Organization	Kao Corporation
Division name	Personal Health Care Research
Address	2-1-3, Bunka Sumida-ku, Tokyo
TEL	03-5630-7271
Homepage URL
Email	tsuchiya.shigemi@kao.co.jp

Sponsor
Institute	Kao Corporation
Institute
Department

Funding Source
Organization	Kao Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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	2017 Year 04 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 15 Day
Anticipated trial start date	2016 Year 11 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2017 Year 04 Month 28 Day
Last modified on	2017 Year 04 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031081