UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030281 |
|---|---|
| Receipt number | 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 12:08:27 |
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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
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
takuro@sleep-t.com
Sponsor or person
Institute
Sleep clinic Chofu
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034578
