UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033729 |
|---|---|
| Receipt number | 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 | 2024/02/16 10:00:47 |
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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
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
maki-eri@yu-dent.ac.jp
Sponsor or person
Institute
Kyushu Dental University
Institute
Department
Personal name
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
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
Terminated
Date of protocol fixation
| 2018 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 28 | Day |
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
| 2024 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038420
