UMIN-CTR Clinical Trial

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	Delay expected
Results Delay Reason	Due to COVID-19 pandemic
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	2022 Year 04 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043503