UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness of oral myofunctional therapy combined with respiratory adjustment
Acronym	Effectiveness of oral myofunctional therapy combined with respiratory adjustment
Scientific Title	Effectiveness of oral myofunctional therapy combined with respiratory adjustment
Scientific Title:Acronym	Effectiveness of oral myofunctional therapy combined with respiratory adjustment
Region	Japan

Condition
Condition	Mouth breathing
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Hypothesizing that promoting nasal breathing will have a lasting effect on OMFTs, we will focus on yoga and compare its effectiveness in combination with oral myofunctional therapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Peak Nasal Inspiratory Flow Lip Closure Force Tongue Up Force
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	yoga
Interventions/Control_2	MFT
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	person with a nasal obstruction
Key exclusion criteria	In treatment of ENT
Target sample size	50

Research contact person
Name of lead principal investigator	1st name SUZUKI Middle name Last name HIROSHI
Organization	Nihon University School of Dentistry at Matsudo
Division name	Department of Oral Function and Fixed Prosthodontics,
Zip code	271-0061
Address	2-870-1 Sakaecho Nishi Matsudo Chiba 271-0061
TEL	047-360-9642
Email	suzuki.hiroshi91@nihon-u.ac.jp

Public contact
Name of contact person	1st name SUZUKI Middle name Last name HIROSHI
Organization	Nihon University School of Dentistry at Matsudo
Division name	Department of Oral Function and Fixed Prosthodontics,
Zip code	271-0061
Address	2-870-1 Sakaecho Nishi Matsudo Chiba 271-0061
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 271-0061
Tel	047-360-9642
Email	suzuki.hiroshi91@nihon-u.ac.jo

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	2021 Year 06 Month 25 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	Open public recruiting
Date of protocol fixation	2020 Year 07 Month 10 Day
Date of IRB	2020 Year 08 Month 17 Day
Anticipated trial start date	2020 Year 08 Month 18 Day
Last follow-up date	2022 Year 02 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 06 Month 25 Day
Last modified on	2021 Year 06 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050999