UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019423 |
|---|---|
| Receipt number | 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 16:13:13 |
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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
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
k-fuku@jf7.so-net.ne.jp
Sponsor or person
Institute
Keio University school of medicine pulmonary division
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021082
