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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013935
Receipt No. R000016249
Scientific Title Clinical Trial of Tongue Stabilizing Device for Down Syndrome Patients with Obstructive Sleep Apnea
Date of disclosure of the study information 2014/06/01
Last modified on 2017/05/14

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Basic information
Public title Clinical Trial of Tongue Stabilizing Device for Down Syndrome Patients with Obstructive Sleep Apnea
Acronym TSD trial for Down syndrome with OSA
Scientific Title Clinical Trial of Tongue Stabilizing Device for Down Syndrome Patients with Obstructive Sleep Apnea
Scientific Title:Acronym TSD trial for Down syndrome with OSA
Region
Japan

Condition
Condition Obstructive Sleep Apnea
Classification by specialty
Medicine in general Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of tongue stabilizing device for Down syndrome patients with obstructive sleep apnea
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Percentage of 'Treatment responder'

Definition of 'Treatment response':
Good Adherence (use more than 70% days), and improvement of 3%ODI or OSA related symptoms
Key secondary outcomes

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 Treatment by Tongue Stabilizing Device(TSD)
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
6 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Members of Japan Down Syndrome Society
2)Subjects with symptoms below by screening test(questionnaire and pulse oximeter)
- normal level(2< for <18 years, 5< for 18<years) < 3%ODI <30
- more than one OSA related symptoms
- 30<3%ODI if already failed conventional treatment such as CPAP
3) more than 6 years old Down syndrome patient with caregiver who understands and agrees with this study protocol
Key exclusion criteria 1) Subjects want conventional treatment such as CPAP or Oral appliance after screening test
2) Subject who is difficult to participate this study because of severe mental problem
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshinori Higuchi
Organization Kyushu University Hospital
Division name General Dentistry
Zip code
Address 3-1-1 Maidashi Higashi-ku Fukuoka
TEL 092-642-6490
Email higuchi@dent.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroko Tsuda
Organization Hiroko Tsuda
Division name General Dentistry
Zip code
Address 3-1-1 Maidashi Higashi-ku Fukuoka
TEL 092-642-6490
Homepage URL
Email htsuda@dent.kyushu-u.ac.jp

Sponsor
Institute Kyushu University
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research
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
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

Other administrative information
Date of disclosure of the study information
2014 Year 06 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 Completed
Date of protocol fixation
2014 Year 03 Month 18 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 01 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
2014 Year 05 Month 12 Day
Last modified on
2017 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016249

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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