UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A single-blind crossover study examining the efficacy of moisturizing the nasal cavity for sleep difficulty with healthy adult
Title of the study (Brief title)	Effect of moisturizing a nasal cavity on sleep
Region	Japan

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

Objectives
Narrative objectives1	To examine the effects of applying moisturizing mask before bedtime on subjective sleep states and sleep EEG
Basic objectives2	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 sleep EEG
Key secondary outcomes	Subjective measurement for psychological states and objective measurement for heart rate variability

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
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	Adaptation (1 day) -> Treatment A (3 days) -> Washout (3 days) -> Adaptation (1 day) -> Treatment B (3 days) Treatment A: Applying a moisture rich mask for 15 min before bedtime once a day for 3 days Treatment B: Applying a moisture poor mask for 15 min before bedtime once a day for 3 days
Interventions/Control_2	Adaptation (1 day) -> Treatment B (3 days) -> Washout (3 days) -> Adaptation (1 day) -> Treatment A (3 days) Treatment A: Applying a moisture rich mask for 15 min before bedtime once a day for 3 days Treatment B: Applying a moisture poor mask for 15 min before bedtime once a day for 3 days
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	30 years-old <=
Age-upper limit	49 years-old >=
Gender	Male
Key inclusion criteria	1) Subjects who have mild sleep difficulty indicated by Pittsburgh sleep quality index score in the range of 6-8 2) Subjects with mild anxiety indicated by Trait-STAI inventory in the range of 33-52
Key exclusion criteria	1) Subjects with irregular sleep/wake patterns such as shift workers 2) Subjects who receive a treatment for physical disorders and/or psychological disorders 3) Subjects who use medicines for sleep 4) Subjects who have dermatological disorders around their mouth and nose. 5) Subjects who realize that their bedroom environments disturb their sleep 6) short sleepers (less than 5 hours) 7) Someone who will not be able to conduct this experiment in their houses 8) Subjects who have history of allergy for surgical tapes 9) Subjects who feel uncomfortable with wearing a mask. 10) smokers 11) Subjects who take a nightcap
Target sample size	25

Research contact person
Name of lead principal investigator	Makoto Uchiyama
Organization	Nihon University School of Medicine
Division name	Department of Psychiatry
Address	30 - 1, Oyaguchi-Kamicho, Itabashi-ku, Tokyo
TEL	03-3972-8111
Email	uchiyama.makoto@nihon-u.ac.jp

Public contact
Name of contact person	Kenta Kakiuchi
Organization	Kao Corporation
Division name	Personal Health Care Research
Address	2-1-3, Bunka Sumida-ku, Tokyo
TEL	03-5630-7271
Homepage URL
Email	kakiuchi.kenta@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	2016 Year 12 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 24 Day
Anticipated trial start date	2017 Year 01 Month 14 Day
Last follow-up date	2017 Year 02 Month 10 Day
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	2016 Year 12 Month 16 Day
Last modified on	2017 Year 06 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029103