UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025298 |
|---|---|
| Receipt number | 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 13:14:02 |
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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
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
kakiuchi.kenta@kao.co.jp
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029103
