UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032620 |
|---|---|
| Receipt number | 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 12:15:16 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
yharutaka@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
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
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
Value
https://center6.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 |
