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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033729
Receipt No. R000038420
Scientific Title Effect of tongue and the mandibular exercise for obstructive sleep apnea
Date of disclosure of the study information 2018/08/30
Last modified on 2019/08/14

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Basic information
Public title Effect of tongue and the mandibular exercise for obstructive sleep apnea
Acronym Effect of exercise for obstructive sleep apnea
Scientific Title Effect of tongue and the mandibular exercise for obstructive sleep apnea
Scientific Title:Acronym Effect of exercise for obstructive sleep apnea
Region
Japan

Condition
Condition obstructive sleep apnea
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine whether tongue and mandibular exercise is useful for improvement of the symptoms of obstructive sleep apnea.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes volume of the upper airway
Key secondary outcomes neck circumference
the distance between most retruded position to most protrusive position
the hardness of suprahyoid muscles group
body mass index
Oxygen Desaturation Index (ODI)
nutrition state

Base
Study type Interventional

Study design
Basic design expanded access
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 Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 tongue and the mandibular exercise 3 times in a day (before each meal) for three months
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 1. subjects who has normal dentulous
2. subjects who is more than 20 years of age
Key exclusion criteria 1. subjects who has underwent orthodontic therapy
2. subjects who is on a diet
3. subjects with craniofacial disorders
4. subjects with multiple teeth loss

Target sample size 14

Research contact person
Name of lead principal investigator
1st name Eri
Middle name
Last name Makihara
Organization Kyushu Dental University
Division name Division of Occlusion & Maxillofacial Reconstruction
Zip code 8038580
Address 2-6-1 Manazuru, Kokura- Kita-Ku, Kitakyushu, Japan
TEL 093-582-1131
Email maki-eri@yu-dent.ac.jp

Public contact
Name of contact person
1st name Eri
Middle name
Last name Makihara
Organization Kyushu Dental University
Division name Division of Occlusion & Maxillofacial Reconstruction
Zip code 8038580
Address 2-6-1 Manazuru, Kokura- Kita-Ku, Kitakyushu, Japan
TEL 093-582-1131
Homepage URL
Email maki-eri@yu-dent.ac.jp

Sponsor
Institute Kyushu Dental University
Institute
Department

Funding Source
Organization None
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 Kyushu Dental University
Address 2-6-1 Manazuru, Kokura-Kita-Ku, Kitakyushu
Tel 093-582-1131
Email maki-eri@kyu-dent.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
2018 Year 08 Month 30 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
2018 Year 08 Month 06 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 04 Month 01 Day
Date trial data considered complete
2021 Year 04 Month 21 Day
Date analysis concluded
2021 Year 04 Month 21 Day

Other
Other related information

Management information
Registered date
2018 Year 08 Month 13 Day
Last modified on
2019 Year 08 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038420

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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