UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005892
Receipt number 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 14:14:43

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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 or person

Institute

Nihon University Surugadai Hospital

Institute

Department

Personal name



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

Value
https://center6.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