UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036055 |
|---|---|
| Receipt number | R000041035 |
| Scientific Title | Efficacy of mouth breathing prevention tape during sleep in healthy adults: A randomized crossover study |
| Date of disclosure of the study information | 2019/04/02 |
| Last modified on | 2020/10/07 18:17:33 |
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Basic information
Public title
Efficacy of mouth breathing prevention tape during sleep in healthy adults: A randomized crossover study
Acronym
Efficacy of mouth breathing prevention tape during sleep: A randomized crossover study
Scientific Title
Efficacy of mouth breathing prevention tape during sleep in healthy adults: A randomized crossover study
Scientific Title:Acronym
Efficacy of mouth breathing prevention tape during sleep: A randomized crossover study
Region
| Japan |
Condition
Condition
healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine with crossover method whether mouth breathing prevention tape during sleep improves quality of sleep using sleep diary and smartphone sleep application.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In the MBS (mouth breathing during sleep) group, we compare the PSQI (Pittsburgh Sleep Quality Index) total score in the sleep questionnaire and the assignment to the total sleeping time and the deep sleep time recorded by "Sleep Meister" with "refreshing feeling upon getting up", with or without.
Key secondary outcomes
We compare the PSQI total scores before, during and after the intervention, and the "refreshing feeling upon getting up" and the ratio of the deep sleep time recorded by "Sleep Meister" and the total sleeping time in the MBS group and the NBS (nasal breathing during sleep) group.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
For 7 days, the subject sticks a mouth breathing prevention tape and take a sleeps.
Interventions/Control_2
No treatment
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy 20-65 year old men and women
No obesity (BMI less than 30)
Key exclusion criteria
In case of nose blockage
When there is wound / rash on the lips and skin around the lips
When their lips and skin are fragile
When drugs are used regularly
In case of pregnancy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Tani |
Organization
Tokushima University Hospital
Division name
Department of General Medicine and Primary Care
Zip code
770-8503
Address
3-18-15 Kuramoto-cho, Tokushima 770-8503, Japan
TEL
088-633-9614
taniken@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Harutaka |
| Middle name | |
| Last name | Yamaguchi |
Organization
Tokushima University Graduate School of Biomedical Sciences
Division name
Department of General Medicine
Zip code
770-8503
Address
3-18-15 Kuramoto-cho, Tokushima 770-8503, Japan
TEL
088-633-9656
Homepage URL
yharutaka@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Non
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Center for Developmental Therapeutics, Tokushima University Hospital
Address
2-50-1 Kuramoto-cho, Tokushima 770-8503, Japan
Tel
088-633-9294
awachiken@tokushima-u.ac.jp
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
徳島大学（徳島県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | Month | 02 | 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
10
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
| 2019 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 02 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 01 | Day |
Last modified on
| 2020 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041035
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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