UMIN-CTR Clinical Trial

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
Email	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
Email	shu.inukai.rpro@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017437