UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005892
Receipt No. R000006958
Scientific Title Study of voice therapy planning for severe voice disorders using high speed imaging and phonatory function testing
Date of disclosure of the study information 2011/07/01
Last modified on 2014/06/26

* 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 Study of voice therapy planning for severe voice disorders using high speed imaging and phonatory function testing
Acronym Study of voice therapy planning
Scientific Title Study of voice therapy planning for severe voice disorders using high speed imaging and phonatory function testing
Scientific Title:Acronym Study of voice therapy planning
Region
Japan

Condition
Condition severe voice disorders
Classification by specialty
Oto-rhino-laryngology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to customize and evaluate a treatment plan suitable for the individual patient, rather than using a standard uniform treatment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes High-speed imaging and aerodynamic phonatory function test
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
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 3
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Laryngo-microsurgery
Interventions/Control_2 Drug therapy
Interventions/Control_3 Voice therapy
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 with severe voice disorders
Key exclusion criteria Patients without severe voice disorders
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyoshi Makiyama
Organization Nihon University Suruagdai Hospital
Division name Otorhinolaryngology
Zip code
Address 1-8-13 Kandasurugadai, Chiyoda, Tokyo 141-0021
TEL 03-3293-1711
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kiyoshi Makiyama
Organization Nihon University Surugadai Hospital
Division name Otorhinolaryngology
Zip code
Address 1-8-13 Kandasurugadai, Chiyoda, Tokyo
TEL 03-3293-1711
Homepage URL
Email makiyama.kiyoshi@nihon-u.ac.jp

Sponsor
Institute Nihon University Surugadai Hospital
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research (C)
Organization
Division
Category of Funding Organization
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 駿河台日本大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2011 Year 07 Month 01 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
2011 Year 06 Month 09 Day
Date of IRB
Anticipated trial start date
2011 Year 07 Month 01 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
2011 Year 06 Month 30 Day
Last modified on
2014 Year 06 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006958

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.