UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025221
Receipt number R000028959
Scientific Title Analysis of voice disorder in spasmodic dysphonia using simultaneous monitoring of vocal fold vibration, laryngeal motion and acoustic signals
Date of disclosure of the study information 2017/01/01
Last modified on 2021/01/27 07:48:42

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Basic information

Public title

Analysis of voice disorder in spasmodic dysphonia using simultaneous monitoring of vocal fold vibration, laryngeal motion and acoustic signals

Acronym

Analysis of voice disorder in spasmodic dysphonia

Scientific Title

Analysis of voice disorder in spasmodic dysphonia using simultaneous monitoring of vocal fold vibration, laryngeal motion and acoustic signals

Scientific Title:Acronym

Analysis of voice disorder in spasmodic dysphonia

Region

Japan


Condition

Condition

spasmodic dysphonia

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To specify the acoustic features of voice in spasmodic dysphonia and to investigate the relationship between laryngeal motor disturbance and abnormal voice.

Basic objectives2

Others

Basic objectives -Others

To make simultaneous recording of
acoustic waveform, glottal pulse and laryngeal movement using electro- and photoglottogram and to make comparison with the normal controls.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Acoustic features of voice: pitch perturbation, disturbance of periodicity and voice break.

Key secondary outcomes

Output of electroglottogram and photoglottogram


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

2

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

voice recording of test sentence reading

Interventions/Control_2

Output of photo- and electroglottogram

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

Expression of full voluntary participation in the research after the full disclosure and understanding of the project plan.

Key exclusion criteria

1. Organic abnormality or paralysis of the larynx.
2. Judgement of unsuitability for inclusion by the chief resercher

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akihiro Homma

Organization

Hokkaido University Hospital

Division name

Department of Otolaryngology, Head and Neck Surgery

Zip code


Address

7-15, Kita-ku, 0808638, Sapooro, Japan

TEL

011-706-5958

Email

ak-homma@med.hokudai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Noriko Nishizawa

Organization

Health Sciences University of Hokkaido

Division name

School of Rehabilitation Sciences

Zip code


Address

1757, Kanazawa Tobetsu, 0610293, Ishikari-gun

TEL

0133-23-1211

Homepage URL


Email

nisizawa@hoku-iryo-u.ac.jp


Sponsor or person

Institute

Department of Otolaryngology, Head and Neck Surgery, Hokkaido University Hospital

Institute

Department

Personal name



Funding Source

Organization

New Energy and Industrial Technology Organization

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


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

北海道大学病院(北海道)
北海道医療大学病院(北海道)


Other administrative information

Date of disclosure of the study information

2017 Year 01 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

1

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 11 Month 18 Day

Date of IRB

2017 Year 01 Month 04 Day

Anticipated trial start date

2017 Year 01 Month 01 Day

Last follow-up date

2020 Year 03 Month 26 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 12 Month 12 Day

Last modified on

2021 Year 01 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028959


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name