UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000032620
Receipt No. R000037189
Scientific Title Efficacy of mouth breathing prevention tape during sleep in healthy person
Date of disclosure of the study information 2018/06/04
Last modified on 2020/11/17 (Ver. 7)

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Basic information
Public title Efficacy of mouth breathing prevention tape during sleep in healthy person
Acronym Efficacy of mouth breathing prevention tape during sleep
Scientific Title Efficacy of mouth breathing prevention tape during sleep in healthy person
Scientific Title:Acronym 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
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 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
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 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)

IRB Contact (For public release)
Organization Tokushima University Hospital Clinical Research Center
Address 2-50-1 Kuramoto, Tokushima 770-8503, Japan
Tel 088-633-9294
Email first-ec@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

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 04 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 6
Results 
Since one of the six candidates was suspected of having sleep apnea, the procedure was conducted on the remaining five healthy men (20 to 22 years old) who obtained their consent.
All pre-intervention PSQI scores were less than 6 and no sleep disorder was present.
All three participants with a PSQI score of 4 or higher answered that they would like to continue using the tape (p = 0.025). They also had poor sleep quality, dry mouth when waking up, or sore throat when waking up before the intervention.
Results date posted
2020 Year 11 Month 17 Day
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
2018 Year 05 Month 16 Day
Date of IRB
2018 Year 06 Month 04 Day
Anticipated trial start date
2018 Year 06 Month 05 Day
Last follow-up date
2020 Year 08 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 17 Day
Last modified on
2020 Year 11 Month 17 Day


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