UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Auditory temporal processing in hearing-impaired person
Title of the study (Brief title)	Auditory temporal processing in hearing-impaired person
Region	Japan

Condition
Condition	hearing impairments
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	we investigated the effects of fast speech for hearing-impaired person.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Fast speech test
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	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Time-compressed speech test(ratio of 0.75, 0.5 to the natural speaking rate)
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Hearing aid or cholea implant users
Key exclusion criteria	Less than 19 years old and 81 years old or older
Target sample size	80

Research contact person
Name of lead principal investigator	Tetsuo Ikezono
Organization	Saitama Medical University
Division name	Otorhinolaryngology
Address	38 Morohongou Moroyamacho Irumagun Saitama
TEL	0492761296
Email	saitama.kikoe@gmail.com

Public contact
Name of contact person	Kei Sakamoto
Organization	Saitama Medical University Hospital
Division name	Otorhinolaryngology
Address	38 Morohongou Moroyamacho Irumagun Saitama
TEL	0492761296
Homepage URL
Email	saitama.kikoe@gmail.com

Sponsor
Institute	Saitama Medical University Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 10 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 01 Day
Anticipated trial start date	2015 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 09 Month 24 Day
Last modified on	2018 Year 10 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022072