UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041305
Receipt number R000047166
Scientific Title Does the oral myofunctional therapy with breathing regulation continue the effect?
Date of disclosure of the study information 2020/08/04
Last modified on 2020/08/04 12:52:07

* 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

Does the oral myofunctional therapy with breathing regulation continue the effect?

Acronym

Does the oral myofunctional therapy with breathing regulation continue the effect?

Scientific Title

Does the oral myofunctional therapy with breathing regulation continue the effect?

Scientific Title:Acronym

Does the oral myofunctional therapy with breathing regulation continue the effect?

Region

Japan


Condition

Condition

mouth breathing

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

When we focus on yoga as breathing training and perform with oral myofunctional therapy, it is compared with promoting effect of oral myofunctinal therapy between peak nasal inspiratory flow, lip closure force, tongue up force and nose obstructive symptoms evaluation.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Peak Nasal Inspiratory Flow; PNIF
Lip Closure Force; LCF
Tongue Up Force; TUP
Nose Obstructive Symptoms Evaluation; NOSE

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

The breathing training

Interventions/Control_2

Oral myofunctional therapy

Interventions/Control_3

The breathing training + oral myofunctional therapy

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

70 years-old >

Gender

Male and Female

Key inclusion criteria

Those who have a high NOSE score and a low PNIF, or those who have a low NOSE score and a low PNIF are the subjects of this experiment.

Key exclusion criteria

Those who are undergoing otolaryngology are excluded.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Hiroshi
Middle name
Last name Suzuki

Organization

Nihon University school of dentistry at Matsudo

Division name

Division of oral function and rehabilitation, department of oral health science

Zip code

271-8587

Address

2-870-1, Sakaecho-nishi, Matsudo, Chiba, Japan

TEL

047-360-9642

Email

suzuki.hiroshi91@nihon-u.ac.jp


Public contact

Name of contact person

1st name Hiroshi
Middle name
Last name Suzuki

Organization

Nihon University school of dentistry at Matsudo

Division name

Division of oral function and rehabilitation, department of oral health science

Zip code

271-8587

Address

2-870-1, Sakaecho-nishi, Matsudo, Chiba, Japan

TEL

047-360-9642

Homepage URL


Email

suzuki.hiroshi91@nihon-u.ac.jp


Sponsor or person

Institute

Nihon University school of dentistry at Matsudo

Institute

Department

Personal name



Funding Source

Organization

Nihon University school of dentistry at Matsudo

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

Nihon University school of dentistry at Matsudo

Address

2-870-1, Sakaecho-nishi, Matsudo, Chiba, Japan

Tel

047-360-9642

Email

suzuki.hiroshi91@nihon-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

2020 Year 08 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


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

2020 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2020 Year 09 Month 01 Day

Last follow-up date

2021 Year 12 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

2020 Year 08 Month 04 Day

Last modified on

2020 Year 08 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047166


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name