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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032620
Receipt No. R000037189
Official scientific title of the study Efficacy of mouth breathing prevention tape during sleep in healthy person
Date of disclosure of the study information 2018/06/04
Last modified on 2018/05/17

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Basic information
Official scientific title of the study Efficacy of mouth breathing prevention tape during sleep in healthy person
Title of the study (Brief title) Efficacy of mouth breathing prevention tape during sleep
Region
Japan

Condition
Condition Healthy
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 For a healthy person with mouth breathing during sleep, we examine whether the mouth breathing prevention tape improves sleep quality using a sleep questionnaire and polysomnogram.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Total score of Pittsburgh Sleep Quality Index (PSQI) and the score of last qustion of the PSQI "how would you rate your sleep quality overall?" (Evaluate before intervention and 3, 8, 15, 22, 29, 30 days after intervention)
The percentage of each sleep depth to total sleep time by using polysomnogram (Evaluate before intervention and 4 weeks after starting intervention)
Key secondary outcomes Total sleep time by using polysomnogram (Evaluate before intervention and 4 weeks after starting intervention)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 For 30 days, the subject sticks a mouth breathing prevention tape and take a sleeps.
Interventions/Control_2
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
25 years-old >=
Gender Male
Key inclusion criteria Healthy 20-25 year old male.
Those who have sore throat when getting up and were suspected mouth breathing during sleep.
Key exclusion criteria When the subject has feeling of nose blockage.
When the subject has wound / skin rash on the lip and around the lip.
When the subject's lips and skin are fragile.
When the subject regularly uses drugs.
Target sample size 10

Research contact person
Name of lead principal investigator Kenji Tani
Organization Tokushima University Hospital
Division name Department of General Medicine and Primary Care
Address 18-15 Kuramoto-cho 3, Tokushima 770-8503, Japan
TEL 088-633-9614
Email taniken@tokushima-u.ac.jp

Public contact
Name of contact person Harutaka Yamaguchi
Organization Tokushima University Graduate School of Biomedical Sciences
Division name Department of General Medicine
Address 18-15 Kuramoto-cho 3, 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 No
Organization
Division
Category of Funding Organization Other
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
2018 Year 06 Month 04 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 05 Month 16 Day
Anticipated trial start date
2018 Year 06 Month 05 Day
Last follow-up date
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
2018 Year 05 Month 17 Day
Last modified on
2018 Year 05 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037189

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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