UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057125 |
|---|---|
| Receipt number | R000065060 |
| Scientific Title | Effects of improved tongue function on obstructive sleep apnea |
| Date of disclosure of the study information | 2025/03/01 |
| Last modified on | 2025/02/12 15:38:48 |
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Basic information
Public title
Effects of improved tongue function on obstructive sleep apnea
Acronym
Tongue function and obstructive sleep apnea
Scientific Title
Effects of improved tongue function on obstructive sleep apnea
Scientific Title:Acronym
Tongue function and 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 aim of this study is to assess tongue function and obstructive sleep apnoea in patients treated with a tongue right positioner (TRP) for obstructive sleep apnoea and to clarify this relationship.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The change of apnea hypopnea index (AHI) after three month treatment of tongue right positioner.
Key secondary outcomes
The change of tongue pressure after three month treatment of tongue right positioner.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Tongue Right Positioner
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Apnea hypopnea index >= 5, Body mass index < 30
Key exclusion criteria
Tonsil hypertrophy, Central apnoea, Under orthodontic treatment, Neuromuscular disorders
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | OKUNO |
| Middle name | |
| Last name | Kentaro |
Organization
Osaka Dental University
Division name
Department of Geriatric Dentistry
Zip code
540-0008
Address
1-5-17, Otemae, Chuo-ku, Osaka, Japan, 540-0008
TEL
06-6910-1521
okuno-kentaro-ig@alumni.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | OKUNO |
| Middle name | |
| Last name | Kentaro |
Organization
Osaka Dental University
Division name
Department of Geriatric Dentistry
Zip code
540-0008
Address
1-5-17, Otemae, Chuo-ku, Osaka, Japan, 540-0008
TEL
06-6910-1521
Homepage URL
okuno-kentaro-ig@alumni.osaka-u.ac.jp
Sponsor or person
Institute
Department of Geriatric Dentistry, Osaka Dental University
Institute
Department
Personal name
Kentaro OKUNO
Funding Source
Organization
Grant-in-Aid for Scientific Research (C)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee of Osaka Dental University
Address
8-1, Kashiwa Hanazonocho, Hirakata, Osaka, Japan, 573-1121
Tel
072-864-3091
oduresearch@cc.osaka-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
大阪歯科大学（大阪府）
順天堂大学医学部附属順天堂医院（東京都）
日本大学松戸歯学部付属病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2030 | 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
| 2025 | Year | 02 | Month | 25 | Day |
Last modified on
| 2025 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065060
