UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025298
Receipt No. R000029103
Scientific Title A single-blind crossover study examining the efficacy of moisturizing the nasal cavity for sleep difficulty with healthy adult
Date of disclosure of the study information 2016/12/16
Last modified on 2017/06/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A single-blind crossover study examining the efficacy of moisturizing the nasal cavity for sleep difficulty with healthy adult
Acronym Effect of moisturizing a nasal cavity on sleep
Scientific Title A single-blind crossover study examining the efficacy of moisturizing the nasal cavity for sleep difficulty with healthy adult
Scientific Title:Acronym 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
1st name
Middle name
Last name Makoto Uchiyama
Organization Nihon University School of Medicine
Division name Department of Psychiatry
Zip code
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
1st name
Middle name
Last name Kenta Kakiuchi
Organization Kao Corporation
Division name Personal Health Care Research
Zip code
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)

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 12 Month 16 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
2016 Year 11 Month 24 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000029103

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.