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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036055
Receipt No. 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

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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
Email 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
Email yharutaka@tokushima-u.ac.jp

Sponsor
Institute Tokushima University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041035

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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