UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of new screening methods for obstructive sleep apnea using perioral muscle activity evaluation
Title of the study (Brief title)	Development of new screening methods for obstructive sleep apnea using perioral muscle activity evaluation
Region	Japan

Condition
Condition	obstructive sleep apnea
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We examined the relation of the tongue pressure and apnea hypopnea index of obstructive sleep apnea patients, to confirm the severity factor of sleep apnea.
Basic objectives2	Others
Basic objectives -Others	Search of severity factor
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	tongue pressure
Key secondary outcomes	apnea hypopnea index

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	Tongue pressure measurement by the tongue pressure measuring instrument for obstructive sleep apnea patients
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	Obstructive sleep apnea patients scheduled for PSG
Key exclusion criteria	Patients with secondary abnormalities in maxillofacial form
Target sample size	150

Research contact person
Name of lead principal investigator	Furuhashi Akifumi
Organization	Aichi Medical University Hospital
Division name	Oral and Maxillofacial Surgery
Address	1-1 Yazakokarimata Nagakute Aichi
TEL	0561-62-3311
Email	aki0102@aichi-med-u.ac.jp

Public contact
Name of contact person	Furuhashi Akifumi
Organization	Aichi Medical University Hospital
Division name	Oral and Maxillofacial Surgery
Address	1-1 Yazakokarimata Nagakute Aichi
TEL	0561-62-3311
Homepage URL
Email	aki0102@aichi-med-u.ac.jp

Sponsor
Institute	Aichi Medical University Hospital
Institute
Department

Funding Source
Organization	Aichi Medical University Hospital
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	愛知医科大学病院

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 08 Month 31 Day
Anticipated trial start date	2016 Year 09 Month 01 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	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 09 Month 01 Day
Last modified on	2018 Year 03 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027273