UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013935 |
|---|---|
| Receipt number | 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 18:57:51 |
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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
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
htsuda@dent.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016249
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
