UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039637 |
|---|---|
| Receipt number | R000044101 |
| Scientific Title | Effect of palatal width of upper oral appliance on respiratory status during sleep |
| Date of disclosure of the study information | 2020/03/31 |
| Last modified on | 2020/02/28 18:14:12 |
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Basic information
Public title
Effect of palatal width of upper oral appliance on respiratory status during sleep
Acronym
Oral appliance and respiratory status
Scientific Title
Effect of palatal width of upper oral appliance on respiratory status during sleep
Scientific Title:Acronym
Oral appliance and respiratory status
Region
| Japan |
Condition
Condition
sleep apnea
Classification by specialty
| Pneumology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
How changes in palatal length of a upper oral appliance can affect the airway patency of a healthy subject by analyzing their sleep variables especially respiratory event index (REI) while wearing the splint during their sleep.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
REI (Respiratory event index)
ODI (Oxygen desaturation index)
Key secondary outcomes
SpO2
Soring sound
Sleep quality
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Oral apliance of 3 types
1.normal palatal width
2.wide palatal width
3.large vertical thickness
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
Epworth scale score (less than 10)
Regular nocturnal sleeper
Key exclusion criteria
1.Symptoms of Temporomandibular Joint Disorders (only sound is OK)
2.severe sleep bruxism
3.moderate to severe nasal disorders
4/untreated missing teeth except wisdom teeth
5.Not under current occlusal splint therapy
6.taking any medication currently for psychiatric disorders
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Nishiyama |
Organization
Tokyo Medical and Dental University
Division name
Orofacial Pain Management
Zip code
113-8549
Address
1-5-45 yushima bunkyo-ku tokyo
TEL
03-5803-5713
anishi.tmj@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Nishiyama |
Organization
Tokyo Medical and Dental University
Division name
Orofacial Pain Management
Zip code
113-8549
Address
1-5-45 yushima bunkyo-ku tokyo
TEL
03-5803-5713
Homepage URL
anishi.tmj@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
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
Ethics review committee, Dental school, Tokyo Medical and Dental University
Address
1-5-45 yushima bunkyo-ku tokyo
Tel
03-5803-5404
d-hyoka.adm@tmd.ac.jp
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
| 2020 | Year | 03 | Month | 31 | 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
| 2020 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 28 | Day |
Last modified on
| 2020 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044101
| 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 |
