UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027394 |
|---|---|
| Receipt number | R000031390 |
| Scientific Title | Clinical efficacy of tongue protruding device(TSD)in obstructive sleep apnea(OSA) |
| Date of disclosure of the study information | 2017/05/18 |
| Last modified on | 2019/11/20 17:09:35 |
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Basic information
Public title
Clinical efficacy of tongue protruding device(TSD)in obstructive sleep apnea(OSA)
Acronym
Clinical efficacy of TSD in OSA
Scientific Title
Clinical efficacy of tongue protruding device(TSD)in obstructive sleep apnea(OSA)
Scientific Title:Acronym
Clinical efficacy of TSD in OSA
Region
| Japan |
Condition
Condition
Obstructive sleep apnea
Classification by specialty
| Pneumology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of clinical effectiveness of TSD and comparison of volume change of upper respiratory tract with OA by MRI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Apnea Hypopnea Index(AHI)
Lowest SpO2 blood pressure(Lowest SpO2)
Key secondary outcomes
Japan Epworth Sleepiness Scale(JESS)
Pittsburgh Sleep Quality Index(PSQI)
Measurement of upper airway volume with MRI.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
One week use of OA
Interventions/Control_2
One week use of TSD
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)Patient with obstructive sleep apnea.
2)Patient who have more than 20 teeth.
3)The amount of mandible protrusion is more than 8mm .
Key exclusion criteria
1)Patient who have diagnosed temporomandiblar disorders.
2)Patient who have diagnosed tongue diseases.
3)Patient who have chronic nosal congestion a high degree of tonsillar hypertrophy.
4)Patient who have diagnosed mental disorders.
5)Patient who need dental treatment for caries and periodontal disease in oral cavity.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hideshima |
| Middle name | |
| Last name | Masayuki |
Organization
Tokyo Medical and Dental University
Division name
Dental Clinic forSleep Disorders
Zip code
113-0051
Address
1-5-45,Yushima,Bunkyo-ku,Tokyo,Japan
TEL
03-5803-4955
m.hideshima.rpro@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Hideshima |
| Middle name | |
| Last name | Masayuki |
Organization
Tokyo Medical and Dental University
Division name
Dental Clinic forSleep Disorders
Zip code
113-0051
Address
1-5-45,Yushima,Bunkyo-ku,Tokyo,Japan
TEL
03-5803-4955
Homepage URL
m.hideshima.rpro@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion Science
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
Tokyo Medical and Dental University
Address
1-5-45,Yushima,Bunkyo-ku,Tokyo,Japan
Tel
03-5803-4955
m.hideshima.rpro@tmd.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
東京医科歯科大学歯学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 18 | 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
12
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
| 2017 | Year | 05 | Month | 18 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 03 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 18 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 18 | Day |
Last modified on
| 2019 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031390
