UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014984 |
|---|---|
| Receipt number | R000017437 |
| Scientific Title | Development of treatment effect prediction method of oral appliance therapy for obstructive sleep apnea syndrome |
| Date of disclosure of the study information | 2014/08/28 |
| Last modified on | 2021/09/02 17:47:39 |
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Basic information
Public title
Development of treatment effect prediction method of oral appliance therapy for obstructive sleep apnea syndrome
Acronym
Development of treatment effect prediction method of oral appliance therapy for obstructive sleep apnea syndrome
Scientific Title
Development of treatment effect prediction method of oral appliance therapy for obstructive sleep apnea syndrome
Scientific Title:Acronym
Development of treatment effect prediction method of oral appliance therapy for obstructive sleep apnea syndrome
Region
| Japan |
Condition
Condition
Obstructive sleep apnea syndrome
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
There are methods, such as snore-test or endoscopy, as method to predict treatment effects in Oral appliance(OA) therapy for obstructive sleep apnea (OSAS). However safe and reliable methods have not yet established.
The impulse oscillation system (IOS) is used at Pneumology, and is possible to measure respiratory resistance and obstructive of airway, and evaluate of the obstruction site. The purpose in this study is to measure respiratory resistance of OSAS patients and, compare with apnea hypopnea index (AHI). We will evaluate whether IOS is effective to prediction of treatment effect in OA therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Respiratory resistance value, Apnea Hypopnea Index (AHI), LowestSpO2
Key secondary outcomes
Cephalometric radiograph, Subjective daytime sleepiness (JESS), Subjective sleep quality(PSQI)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who have received Oral appliance therapy in our hospital, and from whom is written informed consent is obtained in this study
2. Patients who have more than 20 teeth (including the residual anterial teeth)
3. The amount of mandible protrusion is more than 8mm
Key exclusion criteria
1. Patients who have chronic nasal congestion, a high degree of tonsillar hypertrophy
2. Patients who will be received combined OA and nCPAP therapy
3. Patients who have received drug therapy related sleep (hypnotic, anxiolytic)
4. Diagonsed as mental disorders or temporomandibular disorders.
5. Patients who have a complication or history of respiratory disease.
6. Patients who have an allergy against steroids or vasoconstrictor.
7. Patients 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 | |
| Middle name | |
| Last name | Shusuke Inukai |
Organization
Tokyo Medical and Dental University
Division name
Graduate school of Medical and Dental Sciences, Removable partial prosthodontics
Zip code
Address
1-5-45, Yushima, Bunkyo-Ku, Tokyo, 113-8549, Japan
TEL
03-5803-5515
shu.inukai.rpro@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shusuke Inukai |
Organization
Tokyo Medical and Dental University
Division name
Graduate school of Medical and Dental Sciences, Removable partial prosthodontics
Zip code
Address
1-5-45, Yushima, Bunkyo-Ku, Tokyo, 113-8549, Japan
TEL
03-5803-5515
Homepage URL
shu.inukai.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
Nationality of Funding Organization
Japan
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
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
| 2014 | Year | 08 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2077-0383/10/6/1255
Number of participants that the trial has enrolled
27
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
| 2012 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2012 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2014 | Year | 08 | Month | 28 | Day |
Last modified on
| 2021 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017437
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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