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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038164
Receipt No. R000043503
Scientific Title he effect of tongue training using sheet shape supplement on obstructive sleep apnea
Date of disclosure of the study information 2019/11/01
Last modified on 2019/10/01

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Basic information
Public title The effect of tongue training using sheet shape supplement on obstructive sleep apnea
Acronym The effect of Tongue training on sleep apnea
Scientific Title he effect of tongue training using sheet shape supplement on obstructive sleep apnea
Scientific Title:Acronym The effect of Tongue training on sleep apnea
Region
Japan

Condition
Condition Obstructive sleep apnea
Classification by specialty
Pneumology Oto-rhino-laryngology Laboratory medicine
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether training using sheet shaped supplement can improve obstructive sleep apnea.


Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The improve rate of apnea-hypopnea index (AHI) in polysomnography (PSG) after tongue training using sheet shpaed supplement.
Key secondary outcomes

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
Food
Interventions/Control_1 Tongue training using sheet shaped supplment
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

Not applicable
Gender Male and Female
Key inclusion criteria mild or moderate obstructive sleep apnea
Key exclusion criteria severe case, mental illness, neuromuscular diseases
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Yasunari
Middle name
Last name MIyazaki
Organization Tokyo Medical and Dental University
Division name Respiratory Medicine
Zip code 113-8519
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, JAPAN
TEL 81-3-5803-5954
Email miyazaki.pilm@tmd.ac.jp

Public contact
Name of contact person
1st name Meiyo
Middle name
Last name Tamaoka
Organization Tokyo Medical and Dental University
Division name Respiratory Physiology and Sleep Medicine
Zip code 113-8519
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, JAPAN
TEL 81-3-5803-5954
Homepage URL
Email meiyou2.pulm@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Tonguetray Co.,LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo Medicacl and Dental University
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, JAPAN
Tel 81-3-3813-6111
Email meiyou2.pulm@tmd.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
2019 Year 11 Month 01 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
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 Preinitiation
Date of protocol fixation
2019 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 11 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 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 10 Month 01 Day
Last modified on
2019 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043503

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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