UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039936 |
|---|---|
| Receipt number | R000045526 |
| Scientific Title | Examination of muscle stiffness of the submental region in patients with obstructive sleep apnea |
| Date of disclosure of the study information | 2020/03/27 |
| Last modified on | 2023/11/21 16:22:43 |
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Basic information
Public title
Examination of muscle stiffness of the submental region in patients with obstructive sleep apnea
Acronym
Examination of muscle stiffness of the submental region in patients with obstructive sleep apnea
Scientific Title
Examination of muscle stiffness of the submental region in patients with obstructive sleep apnea
Scientific Title:Acronym
Examination of muscle stiffness of the submental region in patients with 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 was to improve our understanding of the physical characteristics of patients with OSA by measuring muscle stiffness in the submental region in both patients with OSA and non-apneic persons.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of submental muscle stiffness at the habitual occlusal position (HOP), the maximum mandibular protrusive position (MPP) and the tongue protrusive position (TPP) during stopping breathing.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
habitual occlusion: HO
Interventions/Control_2
tongue protrusive position: TPP
Interventions/Control_3
maximum mandibular protrusive position: MPP
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients with OSA without other sleep disorders based on overnight PSG test at the medical institutions
healthy participants recruited from dentists or medical staffs of Kyushu Dental University.
Key exclusion criteria
signs and symptoms related to temporomandibular disorders, a history of psychological problems, or occlusion dysfunction
healthy participants with ODI>5
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
803-8580
Address
2-6-1 Manazuru, Kokurakita-ku, Kitakyushu
TEL
093-582-1131
maki-eri@kyu-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
803-8580
Address
2-6-1 Manazuru, Kokurakita-ku, Kitakyushu
TEL
093-582-1131
Homepage URL
maki-eri@kyu-dent.ac.jp
Sponsor or person
Institute
Kyushu Dental University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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, Kokurakita-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
| 2020 | Year | 03 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2018 | Year | 12 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 27 | Day |
Last follow-up date
| 2024 | Year | 03 | 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 | 03 | Month | 25 | Day |
Last modified on
| 2023 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045526
