UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038164
Receipt number 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 2022/04/18 10:18:00

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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 or person

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name



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

Value
https://center6.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