UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of auditory and cognition training to speech perception
Title of the study (Brief title)	Study of auditory training
Region	Japan

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

Objectives
Narrative objectives1	To investigate the effect of auditory and cognitive training for the speech perception.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Speech perception in noise and quiet 10 days, 1 month, 2 months, and 4 month after training.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Intervention group will have the original auditory and cognitive training program in the i-pad for 10 days, 1 month, 2 months, 4 months. They will do the training for about 20 minutes every day
Interventions/Control_2	This group will have the number puzzle and do the puzzle for 20 minutes.
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Adults who have no apparent sign of cognitive defect.
Key exclusion criteria	Those who have cognitive problem
Target sample size	60

Research contact person
Name of lead principal investigator	Tatsuya Yamasoba
Organization	The University of Tokyo Hospital
Division name	Otolaryngology
Address	7-3-1 Hongo Bunkyo-ku Tokyo Japan
TEL	03-5800-8665
Email	tyamasoba-tky@umin.ac.jp

Public contact
Name of contact person	Akinori Kashio
Organization	The University of Tokyo Hospital
Division name	Otolaryngology
Address	7-3-1 Hongo Bunkyo-ku Tokyo Japan
TEL	03-5800-8665
Homepage URL
Email	kashioa-tky@umin.ac.jp

Sponsor
Institute	The University of Tokyo
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2016 Year 01 Month 21 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 10 Month 01 Day
Anticipated trial start date	2016 Year 02 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	2016 Year 01 Month 20 Day
Last modified on	2017 Year 01 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023843