UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research on test battery to evaluate subjective and objective hearing of hearing aid users
Title of the study (Brief title)	Test battery for hearing aid users
Region	Japan

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

Objectives
Narrative objectives1	Perform subjective and objective hearing test on hearing aid users and to determine the appropriate test battery to evaluate hearing aids.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	CI2004 Japanese speech recognition test score.
Key secondary outcomes	Pure tone audiogram, monosyllable recognition test under hearing aid, Speech, Spatial and Qualities of Hearing scale (SSQ) results.

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	Treatment
Type of intervention	Other
Interventions/Control_1	Evaluate Japanese speech recognition ability of hearing aid users using a test (CI2004) designed for cochlear implant users.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Able to understand and decide. 2. Native Japanese speaker. 3. Bilateral hearing loss with >= 45dB hearing threshold in 3-frequency average in both ears. 4. Maximum speech recognition >= 50% at least in one ear. 5. Speech recognition at 50dB <= 50% at least in one ear. 6. Provide written informed consent.
Key exclusion criteria	1. Poor overall health that makes 3 sets of extensive hearing tests invasive. 2. Hearing loss due to bilateral acoustic neuroma. 3. Hearing loss due to intracranial surgery. 4. Hearing loss due to cranial trauma. 5. Scheduled chemotherapy that includes ototoxic anticancer drugs during the research period. 6. Other medical condition that a doctor decides inappropriate to include in the study.
Target sample size	20

Research contact person
Name of lead principal investigator	Torahiko Nakashima
Organization	Kyushu University Hospital
Division name	Department of Otorhinolaryngology
Address	3-1-1 Maidashi Higashi-ku Fukuoka
TEL	81-92-642-5668
Email	nakatora@med.kyushu-u.ac.jp

Public contact
Name of contact person	Nozomu Matsumoto
Organization	Kyushu University Hospital
Division name	Department of Otorhinolaryngology
Address	3-1-1 Maidashi Higashi-ku Fukuoka
TEL	81-92-642-5668
Homepage URL
Email	matunozo@med.kyushu-u.ac.jp

Sponsor
Institute	Kyushu University Hospital
Institute
Department

Funding Source
Organization	Oticon Japan
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Oticon Japan
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 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 04 Day
Anticipated trial start date	2016 Year 02 Month 04 Day
Last follow-up date	2016 Year 12 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/29157624
Results
Other related information

Management information
Registered date	2015 Year 12 Month 05 Day
Last modified on	2017 Year 12 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023191