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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030281
Receipt No. R000034578
Scientific Title Effectiveness of a Nasal Airway Stent for Treatment of Obstructive Sleep Apnea
Date of disclosure of the study information 2017/12/06
Last modified on 2017/12/06

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Basic information
Public title Effectiveness of a Nasal Airway Stent for Treatment of Obstructive Sleep Apnea
Acronym Effect of a Nastent for OSAS
Scientific Title Effectiveness of a Nasal Airway Stent for Treatment of Obstructive Sleep Apnea
Scientific Title:Acronym 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
1st name
Middle name
Last name Takuro Endo
Organization Sleep clinic Chofu
Division name Medical devision
Zip code
Address 2-53-1 Kojima-cho Chofu-shi Tokyo Japan
TEL 0424900700
Email takuro@sleep-t.com

Public contact
Name of contact person
1st name
Middle name
Last name Takuro Endo
Organization Sleep clinic Chofu
Division name Medical devision
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Enrolling by invitation
Date of protocol fixation
2016 Year 02 Month 12 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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