UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012684 |
|---|---|
| Receipt number | R000014665 |
| Scientific Title | Clinical effects of oral appliances therapy for obstructive sleep apnea syndrome by analysis of X-ray findings. |
| Date of disclosure of the study information | 2013/12/25 |
| Last modified on | 2013/12/25 11:36:15 |
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Basic information
Public title
Clinical effects of oral appliances therapy for obstructive sleep apnea syndrome by analysis of X-ray findings.
Acronym
Clinical effects of OA-therapy for OSAS by analysis of X-ray findings.
Scientific Title
Clinical effects of oral appliances therapy for obstructive sleep apnea syndrome by analysis of X-ray findings.
Scientific Title:Acronym
Clinical effects of OA-therapy for OSAS by analysis of X-ray findings.
Region
| Japan |
Condition
Condition
Obstructive Sleep Apnea syndrome
Classification by specialty
| Pneumology | Oral surgery | Dental medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis of mechanism and evidence of the clinical response of OA-therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Decrease of AHI-Index
Improvement of oxygen density in blood
Decrease in snoring
Change of the quality of sleep
Key secondary outcomes
Change of the blood pressure
Improvement of the quality of life
Base
Study type
Interventional
Study design
Basic design
Single arm
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
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Oral Appliances (intraoral-device)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient who can cooperate with a cure using the intraoral device.
The patients having breathing disorder during sleep or OSAS.
Key exclusion criteria
The patient who cannot do under the 18 years old, or edentulous jaw patients, or the person who cannot do the nose breathing at all and others.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takaaki Ueno |
Organization
Osaka medical college
Division name
oral surgery
Zip code
Address
daigakumachi2-7,takatsuki-city,Osaka
TEL
0726-83-1221
ueno@art.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadashi Okutomi |
Organization
Osaka medical college
Division name
oral surgery
Zip code
Address
daigakumachi2-7, takatsuki-city,osaka
TEL
0726-83-1221
Homepage URL
t_okuto@yahoo.co.jp
Sponsor or person
Institute
Takaaki Ueno, Tadashi Okutomi, Yoichiro Nakajima, Toshiyuki Konda
Institute
Department
Personal name
Funding Source
Organization
Osaka medical college
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
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
大阪医科大学（大学院）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 25 | 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
| 2013 | Year | 07 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 09 | 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
| 2013 | Year | 12 | Month | 25 | Day |
Last modified on
| 2013 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014665
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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