UMIN-CTR Clinical Trial

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
Email	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
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	Tokyo Medical and Dental University
Address	1-5-45,Yushima,Bunkyo-ku,Tokyo,Japan
Tel	03-5803-4955
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031390