UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050896 |
|---|---|
| Receipt number | R000057250 |
| Scientific Title | Oral appliance for obstructive sleep apnea and BMI: a scoping review |
| Date of disclosure of the study information | 2023/05/01 |
| Last modified on | 2023/04/20 20:22:38 |
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Basic information
Public title
Oral appliance for obstructive sleep apnea and BMI: a scoping review
Acronym
Oral appliance for obstructive sleep apnea and BMI: a scoping review
Scientific Title
Oral appliance for obstructive sleep apnea and BMI: a scoping review
Scientific Title:Acronym
Oral appliance for obstructive sleep apnea and BMI: a scoping review
Region
| Japan |
Condition
Condition
Obstructive sleep apnea
Classification by specialty
| Pneumology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between BMI and the effect of oral appliance on obstructive sleep apnea.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success rate
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Obstructive sleep apnoea diagnosed by PSG
2 Treatment with oral appliance
3 Determination of treatment efficacy by PSG
4 Calculation of success rate according to arbitrary criteria
5 Calculation of representative values of BMI
6 Written description in English or Japanese
Key exclusion criteria
1 Review
2 Treatment with tongue stabilization device
3 Less than 10 subjects in the study
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Yasue |
| Middle name | |
| Last name | Tanaka |
Organization
Tohoku University Graduate School of Dentistry
Division name
Division
Zip code
9808575
Address
4-1 Seiryo-machi, Aoba-ku, Sendai
TEL
0227178396
yasue.tanaka.b3@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yasue |
| Middle name | |
| Last name | Tanaka |
Organization
Tohoku University Graduate School of Dentistry
Division name
Division of Aging and Geriatric Dentistry
Zip code
9808575
Address
4-1 Seiryo-machi, Aoba-ku, Sendai
TEL
0227178396
Homepage URL
yasue.tanaka.b3@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Yasue Tanaka
Funding Source
Organization
N/A
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
N/A
Address
N/A
Tel
N/A
N/A
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
| 2023 | Year | 05 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Conduct a scoping review of the literature on oral appliance therapy for sleep apnea by searching electronic databases such as Pubmed and Ichushi-web.
Management information
Registered date
| 2023 | Year | 04 | Month | 20 | Day |
Last modified on
| 2023 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057250
