UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044548
Receipt number R000050347
Scientific Title Acoustic diversity in perceptual roughness in voice and its vocalization mechanism.
Date of disclosure of the study information 2021/06/15
Last modified on 2022/03/15 19:38:43

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Basic information

Public title

Acoustic diversity in perceptual roughness in voice and its vocalization mechanism.

Acronym

Perceptual roughness: diversity and mechanism.

Scientific Title

Acoustic diversity in perceptual roughness in voice and its vocalization mechanism.

Scientific Title:Acronym

Perceptual roughness: diversity and mechanism.

Region

Japan


Condition

Condition

voice disorder

Classification by specialty

Oto-rhino-laryngology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To classify types of perceptually rough voice by finding the relationship between the various acoustic features and the laryngeal and expiratory airflow findings during vocalization

Basic objectives2

Others

Basic objectives -Others

Exploratory research

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Relationship between acoustical features and laryngeal high-speed imaging findings

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

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

High-speed laryngeal imaging, electroglottogram, voice recording, and expiratory flow measurement during vocalization

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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Voice disorder patients with a perceptually rough voice
2) Healthy individuals without hoarseness.
Cases of the above whose age is 20 years or older and whose consent to participate in the study have been obtained.

Key exclusion criteria

Patients who meet any of the following conditions will be excluded.
1) Women who are pregnant or may become pregnant
2) Cases of hoarseness due to acute inflammation
3) Patients/healthy people who have difficulty in giving their own consent for research
4) Other patients/healthy people who are judged by the doctor in charge to be inappropriate to participate in this study

Target sample size

130


Research contact person

Name of lead principal investigator

1st name Kiyohito
Middle name
Last name Hosokawa

Organization

Osaka University Graduate School of Medicine

Division name

Department of otorhinolaryngology-head and neck surgery

Zip code

5650871

Address

2-2 Yamadaoka, Suita, Osaka

TEL

06-6879-3951

Email

khosokawa@ent.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name Kiyohito
Middle name
Last name Hosokawa

Organization

Osaka University Graduate School of Medicine

Division name

Department of otorhinolaryngology-head and neck surgery

Zip code

5650871

Address

2-2 Yamadaoka, Suita, Osaka

TEL

06-6879-3951

Homepage URL


Email

khosokawa@ent.med.osaka-u.ac.jp


Sponsor or person

Institute

Osaka University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Academic Clinical Research Center of Osaka University Hospital

Address

2-2, Yamadaoka, Suita, Osaka

Tel

06-6210-8290

Email

rinri@hp-crc.med.osaka-u.ac.jp


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

2021 Year 06 Month 15 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

Open public recruiting

Date of protocol fixation

2021 Year 06 Month 15 Day

Date of IRB

2021 Year 06 Month 28 Day

Anticipated trial start date

2021 Year 07 Month 01 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 06 Month 15 Day

Last modified on

2022 Year 03 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050347


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name