UMIN-CTR Clinical Trial

Basic information
Public title	Phonemic restoration on patients with implantable hearing prostheses
Acronym	Phonemic restoration on implantable hearing device users
Scientific Title	Phonemic restoration on patients with implantable hearing prostheses : comparison between cochlear implants, middle ear implants, and electric acoustic stimulation cochlear implantation
Scientific Title:Acronym	Phonemic restoration on the users of CI, MEI, and EAS
Region	Japan

Condition
Condition	sensorineural hearing loss, mixed/conductive hearing loss
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is determining effects for phonemic restoration by different kinds of implantable hearing prostheses.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correct answer rate for the phonemic restoration examination.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Listening of phoemic restration sentence test.
Interventions/Control_2	Listening of not phonemic restration sentence 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	18 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	Subjests of this study can listen monosylalbic words better than 50%.
Key exclusion criteria	Those are excluded who have cognitive impairment which make doing test difficulty.
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Masae Middle name Last name Shiroma
Organization	Graduate school, International University of Health and Welfare
Division name	Ootawara campus
Zip code	324-8501
Address	2600-1 Kitakanemaru, Ootawara, Tochigi.
TEL	0287-24-3000
Email	mshiroma@iuhw.ac.jp

Public contact
Name of contact person	1st name Masae Middle name Last name Shiroma
Organization	Graduate school, International University of Health and Welfare
Division name	Ootawara campus
Zip code	324-8501
Address	2600-1 Kitakanemaru, Ootawara, Tochigi.
TEL	0287-24-3000
Homepage URL
Email	mshiroma@iuhw.ac.jp

Sponsor
Institute	International University of Health and Welfare.
Institute
Department

Funding Source
Organization	None.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Institutional Review Board, International University of Health and Welfare.
Address	4-1-26 Akasaka, Minato-ku, Tokyo.
Tel	03-5574-3900
Email	rinri-tky@iuhw.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	2022 Year 08 Month 08 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	Preinitiation
Date of protocol fixation	2022 Year 05 Month 31 Day
Date of IRB
Anticipated trial start date	2022 Year 08 Month 08 Day
Last follow-up date	2023 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	2022 Year 07 Month 27 Day
Last modified on	2022 Year 07 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055034