UMIN-CTR Clinical Trial

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
Institute	Nihon University school of dentistry at Matsudo
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047166