UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness of a Nasal Airway Stent for Treatment of Obstructive Sleep Apnea
Title of the study (Brief title)	Effect of a Nastent for OSAS
Region	Japan

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

Objectives
Narrative objectives1	Effectiveness of a Nasal Airway Stent for Treatment of Obstructive Sleep Apnea
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Apnea hypopnea index
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
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
Interventions/Control_1	AHI under no treatment
Interventions/Control_2	AHI using Nastent
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	Obstructive sleep apnea syndrome
Key exclusion criteria	None
Target sample size	90

Research contact person
Name of lead principal investigator	Takuro Endo
Organization	Sleep clinic Chofu
Division name	Medical devision
Address	2-53-1 Kojima-cho Chofu-shi Tokyo Japan
TEL	0424900700
Email	takuro@sleep-t.com

Public contact
Name of contact person	Takuro Endo
Organization	Sleep clinic Chofu
Division name	Medical devision
Address	2-53-1 Kojima-cho Chofu-shi Tokyo Japan
TEL	0424900700
Homepage URL
Email	takuro@sleep-t.com

Sponsor
Institute	Sleep clinic Chofu
Institute
Department

Funding Source
Organization	Sleep clinic Chofu
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	2017 Year 12 Month 06 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 02 Month 12 Day
Anticipated trial start date	2017 Year 12 Month 06 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 12 Month 06 Day
Last modified on	2017 Year 12 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034578