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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024617
Receipt No. 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

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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
Email 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
Email k-okuno@dent.osaka-u.ac.jp

Sponsor
Institute Division for Oral and Facial Disorders, Osaka University Dental Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028321

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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