UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024617 |
|---|---|
| Receipt number | R000028321 |
| Scientific Title | The efficacy of nasal airway stent (nastentTM) in patient with obstructive sleep apnea |
| Date of disclosure of the study information | 2016/11/04 |
| Last modified on | 2017/10/10 09:27:14 |
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Basic information
Public title
The efficacy of nasal airway stent (nastentTM) in patient with obstructive sleep apnea
Acronym
Nastent study
Scientific Title
The efficacy of nasal airway stent (nastentTM) in patient with obstructive sleep apnea
Scientific Title:Acronym
Nastent study
Region
| Japan |
Condition
Condition
obstructive sleep apnea
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to identify the efficacy of nastnet in patients with obstructive sleep apnea
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The change of apnea hypopnea index (AHI) after one month treatment of nastent.
Key secondary outcomes
The change of minimum SpO2 after one month treatment of nastent.
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
Nastent treatment (1 month)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have been diagnosed with obstructive sleep apnea
Key exclusion criteria
Patients who have a neuromuscular disease, severe heart disease and mental disease.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayoshi Sakai |
Organization
Osaka University Graduate School of Dentistry
Division name
Division of Functional Oral Neuroscience
Zip code
Address
1-8, Yamadaoka, Suita-city, Osaka, Japan, 565-0871
TEL
06-6879-2275
sakai@dent.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kentaro Okuno |
Organization
Osaka University Dental Hospital
Division name
Division for Oral and Facial Disorders
Zip code
Address
1-8, Yamadaoka, Suita-city, Osaka, Japan, 565-0871
TEL
06-6879-2278
Homepage URL
k-okuno@dent.osaka-u.ac.jp
Sponsor or person
Institute
Division for Oral and Facial Disorders, Osaka University Dental Hospital
Institute
Department
Personal name
Funding Source
Organization
Division for Oral and Facial Disorders, Osaka University Dental Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
seven dreamers laboratories, inc.
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
大阪大学歯学部附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 04 | 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 | 10 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 05 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 09 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 28 | Day |
Last modified on
| 2017 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028321
