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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019423
Receipt No. R000021082
Scientific Title the effectiveness of the nasal airway stent (nastentTM) in sleep apnea syndrome
Date of disclosure of the study information 2015/10/20
Last modified on 2017/06/26

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Basic information
Public title the effectiveness of the nasal airway stent (nastentTM) in sleep apnea syndrome
Acronym NASstudy
Scientific Title the effectiveness of the nasal airway stent (nastentTM) in sleep apnea syndrome
Scientific Title:Acronym 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
1st name
Middle name
Last name Fukunaga Koichi
Organization Keio University school of medicine
Division name pulmonary devision
Zip code
Address shinanomachi35,shinjyukuku,tokyo
TEL 03-3353-1211
Email k-fuku@jf7.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Fukunaga koichi
Organization Keio University school of medicine
Division name pulmonary devision
Zip code
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)

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 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

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
2015 Year 07 Month 07 Day
Date of IRB
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

Other
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

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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