UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Ramdomized-controlled trial of oral exercise for obstructive sleep apnea syndrome patient who have lower lingual pressure
Title of the study (Brief title)	Ramdomized-controlled trial of oral exercise for obstructive sleep apnea syndrome patient who have lower lingual pressure
Region	Japan

Condition
Condition	obstructive sleep apnea
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate the effectiveness of two types of oral exercise in the treatment of OSAS and their impact on the reduction of AHI(Apnea Hypopnea Index).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	AHI(Apnea Hypopnea Index) after 12weeks from the beginning of treatment
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment Other
Interventions/Control_1	Doing standard oral exercise 30 minitues per day for 12weeks
Interventions/Control_2	Doing oral exercise using tongue training machine 30 minitues per day for 12weeks
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 is over 20-years-old when wrote informed consent (2)AHI>5 (3)Patients from whom written informed consent is obtained in this study (4)Patients whose tongue pressure was lower than 30kPa
Key exclusion criteria	(1)Patients who have severe cardiac disorder (2)Patients who have dementia (3)Patients who have severe neuromuscular disorder (4)Patients who thought to be inadequate
Target sample size	45

Research contact person
Name of lead principal investigator	Tatsuya Nagano
Organization	Kobe University Graduate School of Medicine
Division name	Division of Respiratory Medicine, Department of Internal Medicine,
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL	078-382-5660
Email	tnagano@med.kobe-u.ac.jp

Public contact
Name of contact person	Reina Sekiya
Organization	Kobe University Graduate School of Medicine
Division name	Division of Respiratory Medicine, Department of Internal Medicine,
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL	078-382-5660
Homepage URL
Email	reina.aoyama@gmail.com

Sponsor
Institute	Division of Respiratory Medicine, Department of Internal Medicine,Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	2022 Year 11 Month 30 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 10 Month 25 Day
Anticipated trial start date	2017 Year 11 Month 30 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 10 Month 25 Day
Last modified on	2017 Year 10 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033948