UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of oral appliance on short-term blood pressure variability in patients with obstructive sleep apnea.
Title of the study (Brief title)	Effect of oral appliance on short-term blood pressure variability in patients with obstructive sleep apnea.
Region	Japan

Condition
Condition	Obstructive sleep apnea
Classification by specialty	Pneumology Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether mild to moderate OSA induce short-term blood pressure variability and the effect of OA therapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	Apnea Hypopnea Index (AHI), LowestSpO2,blood pressure,short-term blood pressure,immunoreactive insulin(IRI),HbA1c
Key secondary outcomes	Subjective daytime sleepiness (JESS), Subjective sleep quality(PSQI)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Observation of changes with OA therapy
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	Individual with mild to moderate OSA(5<AHI<30) Individual with normal occlusion Individual with more than 10 teeth in each of upper and lower jaw without severe caries and periodontal disease
Key exclusion criteria	Individual with refusing to cooperation Individual with already treated with CPAP Individual with disable to use OA more than four times a week Individual with starting hypertension treatment during this study Individual with temporomandibular disorders Individual with mental health problems
Target sample size	100

Research contact person
Name of lead principal investigator	Meiyo Tamaoka
Organization	Tokyo Medical and Dental University
Division name	Sleep Modulatory Medicine
Address	1-5-45 YUshima, Bunkyo-ku, Tokyo
TEL	03-5803-4967
Email	meiyo2.pulm@tmd.ac.jp

Public contact
Name of contact person	Meiyo Tamaoka
Organization	Tokyo Medical and Dental University
Division name	Sleep Modulatory Medicine
Address	1-5-45 YUshima, Bunkyo-ku, Tokyo
TEL	03-5803-4967
Homepage URL
Email	meiyo2.pulm@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)

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	2017 Year 03 Month 17 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 03 Month 17 Day
Anticipated trial start date	2017 Year 03 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 03 Month 17 Day
Last modified on	2017 Year 03 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029980