UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039637
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email anishi.tmj@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044101

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.