UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000026427
Receipt No. R000028499
Scientific Title Efficacy of Nasal Speaking Valve (NSV)
Date of disclosure of the study information 2017/03/06
Last modified on 2018/08/06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Efficacy of Nasal Speaking Valve (NSV)
Acronym Efficacy of Nasal Speaking Valve (NSV)
Scientific Title Efficacy of Nasal Speaking Valve (NSV)
Scientific Title:Acronym Efficacy of Nasal Speaking Valve (NSV)
Region
Japan

Condition
Condition velopharyngeal incompetence
Classification by specialty
Oto-rhino-laryngology Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This research aims to reveal the effect of Nasal Speaking Valve (NSV) on various disease condition which causes velopharyngeal incompetence.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Speech intelligibility before and after wearing NSV
Key secondary outcomes

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 wearing NSV
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
6 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patient who shows dysarthria which could be improved by closing nostrils with fingers
Key exclusion criteria nostrils are not large enough to wear NSV
Target sample size 350

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shogo Minagi
Organization Okayama University
Division name Department of Occlusal and Oral Functional Rehabilitation, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama 700-8525
TEL 0862356687
Email minagi@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shogo Minagi
Organization Okayama University
Division name Department of Occlusal and Oral Functional Rehabilitation, Graduate School of Medicine, Dentistry a
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama 700-8525
TEL 0862356687
Homepage URL
Email minagi@md.okayama-u.ac.jp

Sponsor
Institute Okayama University
Institute
Department

Funding Source
Organization Okayama University
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
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

Other administrative information
Date of disclosure of the study information
2017 Year 03 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 Terminated
Date of protocol fixation
2017 Year 01 Month 17 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 17 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 03 Month 06 Day
Last modified on
2018 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028499

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.