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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027394
Receipt No. 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 2018/05/21

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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
Middle name
Last name Hideshima Masayuki
Organization Tokyo Medical and Dental University
Division name Dental Clinic forSleep Disorders
Zip code
Address 1-5-45,Yushima,Bunkyo-ku,Tokyo,Japan
TEL 03-5803-4955
Email m.hideshima.rpro@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideshima Masayuki
Organization Tokyo Medical and Dental University
Division name Dental Clinic forSleep Disorders
Zip code
Address 1-5-45,Yushima,Bunkyo-ku,Tokyo,Japan
TEL 03-5803-4955
Homepage URL
Email m.hideshima.rpro@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

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
Address
Tel
Email

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 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 Open public recruiting
Date of protocol fixation
2017 Year 05 Month 18 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 18 Day
Last follow-up date
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
2018 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031390

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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