UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	the effectiveness of the nasal airway stent (nastentTM) in sleep apnea syndrome
Title of the study (Brief title)	NASstudy
Region	Japan

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

Objectives
Narrative objectives1	the invistigation of the effectiveness of nasal airway device(nastentTM) in sleep apnea syndrome
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	change of AHI after the indication of nasal airway stent(nastentTM) treatment in one month and three months
Key secondary outcomes	frequency of adverse effect after the indication of nasal airway stent(nastentTM)in one month and three months

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	To evaluate the changes of self synptoms used of a questionnaire survey and AHI used of portable instrument before and after the use of nasal airway devices in one month and three months against sleep apnea syndrome 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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	sleep apnea syndrome patients(AHI under20 in PSG)who will recieve a treatment of nasal airway device(nastentTM)
Key exclusion criteria	the patients who cannot continue the use of the nasal airway stent(nastentTM) or attend a hospital
Target sample size	50

Research contact person
Name of lead principal investigator	Fukunaga Koichi
Organization	Keio University school of medicine
Division name	pulmonary devision
Address	shinanomachi35,shinjyukuku,tokyo
TEL	03-3353-1211
Email	k-fuku@jf7.so-net.ne.jp

Public contact
Name of contact person	Fukunaga koichi
Organization	Keio University school of medicine
Division name	pulmonary devision
Address	shinanomachi35,shinjyukuku,tokyo
TEL	03-3353-1211
Homepage URL
Email	k-fuku@jf7.so-net.ne.jp

Sponsor
Institute	Keio University school of medicine pulmonary division
Institute
Department

Funding Source
Organization	seven dreamers laboratories, inc.
Organization
Division
Category of Funding Organization	Profit organization
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	慶應義塾大学病院（東京都）、RESM新横浜睡眠呼吸メディカルクリニック（神奈川県） 新宿睡眠メディカルクリニック(東京都）

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 07 Day
Anticipated trial start date	2015 Year 07 Month 21 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	2015 Year 10 Month 20 Day
Last modified on	2017 Year 06 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021082