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

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 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

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

Value
https://center6.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