UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Auditory evoked potential in patients with bilateral cochlear implantation
Title of the study (Brief title)	AEP in bilateral CI patients
Region	Japan

Condition
Condition	bilateral cochlear implant recipients normal hearing subjects
Classification by specialty	Oto-rhino-laryngology Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To see the central auditory processing in patients with bilateral cochlear implant
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	N100 amplitude and latency
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Bilateral cochlear implant (Coclear ltd) recipients treated at Iwate Medical University or Kyoto University Hospital Patients and normal subjects with informed consent or informed assent (at or younger than 10 years)
Key exclusion criteria	Patients and normal subjects without consent or assent Patients and normal subjects who cannot tolerate the examination without sedative drugs
Target sample size	26

Research contact person
Name of lead principal investigator	Harukazu Hiraumi
Organization	Iwate Medical University
Division name	Otolaryngology, Head and Neck Surgery
Address	19-1, Uchimaru, Morioka, Iwate
TEL	019-651-5111
Email	hhiraumi@ent.kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Harukazu Hiraumi
Organization	Iwate Medical University
Division name	Otolaryngology, Head and Neck Surgery
Address	19-1, Uchimaru, Morioka, Iwate
TEL	019-651-5111
Homepage URL
Email	hhiraumi@ent.kuhp.kyoto-u.ac.jp

Sponsor
Institute	Iwate Medical University
Institute
Department

Funding Source
Organization	Self funding
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 04 Month 01 Day

Progress
Recruitment status	Suspended
Date of protocol fixation	2013 Year 12 Month 19 Day
Anticipated trial start date	2015 Year 04 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	Compare the amplitude and latency of N100 between the CI recipients and normal hearing sujbects

Management information
Registered date	2015 Year 02 Month 19 Day
Last modified on	2017 Year 03 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019027