UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028392
Receipt number R000032506
Scientific Title Exploratory study on word intelligibility in the presence of competing speech for subjects with auditory processing disorders and healthy subjects
Date of disclosure of the study information 2017/07/27
Last modified on 2024/03/01 23:00:29

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Basic information

Public title

Exploratory study on word intelligibility in the presence of competing speech for subjects with auditory processing disorders and healthy subjects

Acronym

Word intelligibility in presence of competing speech

Scientific Title

Exploratory study on word intelligibility in the presence of competing speech for subjects with auditory processing disorders and healthy subjects

Scientific Title:Acronym

Word intelligibility in presence of competing speech

Region

Japan


Condition

Condition

1) healthy subjects
2) auditory processing disorders

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Preliminary investigation for establishment of objective evaluation of hearing difficulty in patients with auditory processing disorders

Basic objectives2

Others

Basic objectives -Others

Establishment of objective evaluation

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Word intelligibility

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

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Healthy subjects/Word intelligibility test

Interventions/Control_2

APD patients/Word intelligibility test

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

15 years-old <=

Age-upper limit

40 years-old >

Gender

Male and Female

Key inclusion criteria

1) Hearing test subjects:
20 subjects with normal hearing participated in the study as a volunteer who agree with the purpose of the research and satisfied the following conditions a) and b)
a) age: 20 years old or older than 20 years, and younger than 40 years old
b)performance status = 0

2)Patients with APD:
20 patients diagnosed with APD (including suspicious cases) who intend to participate as a volunteer in this study and satisfy the following conditions a), b), c)
a) age: 20 years old or older than 20 years, and younger than 40 years old
b) age: 15 years old or older than 15 years, and younger than 20 years old patients who got consent from the parent or guardian for examination
c) Performance status 0

Key exclusion criteria

I) Healthy subjects
1) Past history of the ear disease
2) Subjects with past history of mental disease
3) Subjects with past history of the peripheral or central neurologic disease
4) Subjects with the possibility of the pregnancy
5) Subjects whom researchers judged to be inappropriate
II) patients with APD
1) Subjects with the possibility of the pregnancy
2) Subjects whom researchers judged to be inappropriate

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Tetsuaki
Middle name
Last name Kawase

Organization

Tohoku University

Division name

Graduate School of Biomedical Engineering

Zip code

980-8574

Address

1-1 Seiryo-machi, Aoba-ku, Sendai

TEL

022-717-7303

Email

kawase@orl.med.tohoku.ac.jp


Public contact

Name of contact person

1st name Tetsuaki
Middle name
Last name Kawase

Organization

Tohoku University

Division name

Graduate School of Biomedical Engineering

Zip code

980-8574

Address

1-1 Seiryo-machi, Aoba-ku, Sendai

TEL

022-717-7303

Homepage URL


Email

kawase@orl.med.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University

Institute

Department

Personal name



Funding Source

Organization

the Ministry of Education, Culture, Sports, Science and Technology-Japan

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

Tohoku University Graduate School of Medicine Ethics Committee

Address

2-1 Seiryo-machi, Aoba-ku, Sendai

Tel

022-717-8007

Email

med-kenkyo@grp.tohoku.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

2017 Year 07 Month 27 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

2017 Year 07 Month 27 Day

Date of IRB

2017 Year 08 Month 02 Day

Anticipated trial start date

2017 Year 08 Month 03 Day

Last follow-up date

2022 Year 07 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

2017 Year 07 Month 27 Day

Last modified on

2024 Year 03 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032506


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name