UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory study on word intelligibility evaluation in the presence of competing speech using headphones
Acronym	Evaluation of word intelligibility under competitive speech
Scientific Title	Exploratory study on word intelligibility evaluation in the presence of competing speech using headphones
Scientific Title:Acronym	Evaluation of word intelligibility under competitive speech
Region	Japan

Condition
Condition	Normal volunteers and patients with auditory processing disorders
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Preliminary study for establishment of objective method to evaluate hearing difficulty in patients with auditory processing disorders
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

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	Diagnosis
Type of intervention	Other
Interventions/Control_1	Word intelligibility test
Interventions/Control_2	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) Normal volunteers: 20 normal volunteers with normal hearing who satisfy the following conditions a) and b) a) age: 20 <= age < 40 years old b) Performance status=0 (condition in which daily life can act without any problem)2) Patients with APD: Patients diagnosed as APD (including suspicious cases), among those who intend to participate as volunteers in this study, 20 persons who satisfy the following conditions a), b), c) a) age: 20 <= age < 40 years old b) age: 15 <= age < 20 years, adn those who got consent from the parent or guardian for examinationc) c) Performance status=0 (condition in which daily life can act without any problem)
Key exclusion criteria	Norma subjects 1) A person with a history of ear diseases2) One with a history of mental illness 3) History of peripheral or central neurological disorder 4) Possible pregnancy 5) Those who have judged to be inappropriate as subjects by the researchers APD subjects 1) Possible pregnancy 2) Those who have judged to be inappropriate as subjects by the researchers
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
Institute	Tohoku University
Institute
Department

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	1-1 Seiryo-machi, Aoba-ku
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	2018 Year 02 Month 26 Day

Related information
URL releasing protocol	unpublished
Publication of results	Unpublished

Result
URL related to results and publications	unpublished
Number of participants that the trial has enrolled	26
Results	Word intelligibility under distractors were assesed in normal subjects and patients with suspected auditory processing disorder. Hoowever, it was suggested that it was not suitable for delineating the listening dificulties in the patient group.
Results date posted	2021 Year 01 Month 28 Day
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	2018 Year 02 Month 26 Day
Date of IRB	2018 Year 02 Month 27 Day
Anticipated trial start date	2018 Year 03 Month 01 Day
Last follow-up date	2020 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	2018 Year 02 Month 26 Day
Last modified on	2021 Year 01 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035933