UMIN-CTR Clinical Trial

Basic information
Public title	Effect on snoring and feasibility of Nasal Airway Stent
Acronym	Effect and feasibility of Nasal Airway Stent
Scientific Title	Effect on snoring and feasibility of Nasal Airway Stent
Scientific Title:Acronym	Effect and feasibility of Nasal Airway Stent
Region	Japan

Condition
Condition	Snoring
Classification by specialty	Medicine in general Pneumology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	(1) Examine feasibility of using Nasal Airway Stent (1) Examine the effect of using Nasal Airway Stent on snoring (1) Examine the effect of using Nasal Airway Stent on apnea or hypopnea
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	(1) feasibility of using Nasal Airway Stent Before and After 4 days using Nasal Airway Stent, assessed for 3 days about (2) snoring by digital voice recorder (3) apnea and hypopnea (AHI) by Apnea hypopnea testing apparatus
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Nasal Airway Stent 7 days
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	16 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Subjects who approve to take part in the study as examinees after informed consent
Key exclusion criteria	(1) Patient with sleep apnea syndrome undergoing medical treatment (2) Patient with severe respiratory diseases (3) Patient with severe liver, renal, heart, etc. diseases. (4) Subject who cannot insert Nasal Airway Stent into the nasal cavity (5) Subject who cannot perform examinations (6) Subject judged as inadequate by researcher
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Yuki Middle name Last name Sumi
Organization	Tokyo Medical and Dental University
Division name	School of health sciences, Faculty of Medicine. Biofunctional Informatics, Biomedical Laboratory Science
Zip code	113-8519
Address	1-5-45 Yushima Bunkyo-ku Tokyo 113-8519 Japan
TEL	03-5803-5372
Email	ysumi.pulm@tmd.ac.jp

Public contact
Name of contact person	1st name Yuki Middle name Last name Sumi
Organization	Tokyo Medical and Dental University
Division name	School of health sciences, Faculty of Medicine. Biofunctional Informatics, Biomedical Laboratory Sci
Zip code	113-8519
Address	1-5-45 Yushima Bunkyo-ku Tokyo 113-8519 Japan
TEL	03-5803-5372
Homepage URL
Email	ysumi.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	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokyo Medical and Dental University
Address	1-5-45 Yushima Bunkyo-ku Tokyo 113-8519 Japan
Tel	03-3813-6111
Email	info.bec@tmd.ac.jp

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	2016 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 20 Day
Date of IRB	2016 Year 03 Month 22 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 01 Month 20 Day
Last modified on	2020 Year 01 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023839