UMIN-CTR Clinical Trial

Basic information
Public title	Electric and acoustic stimulation (EAS) type cochlea implantation surgery (2)
Acronym	EAS type cochlea implantation (2)
Scientific Title	Electric and acoustic stimulation (EAS) type cochlea implantation surgery (2)
Scientific Title:Acronym	EAS type cochlea implantation (2)
Region	Japan

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

Objectives
Narrative objectives1	Hearing loss causes serious disability of smooth communication, so the medical treatment using hearing aid or cochlea implantation are important to get out from this situations. The electric and acoustic stimulation (EAS) type cochlea implantation will improve the hearing ability and communication ability of bilateral profound sensorineural hearing loss patients with residual hearing in low frequencies. The EAS has already used clinicaly in Europe and already confirmed the venefit of this system for European population. In this clinical research, we confirm the EAS system venefit in Japanese bilateral profound sensorineural hearing loss patients with residual hearing in low frequencies, and also confirm the safetiness of EAS system in Japanese.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The therapeutic effects are evaluated at 6 month and 12 month after the EAS operation, using the free field audiometry and speech recognition threshold test. In the free field audiometry test, marked recovery is defined as more than 30 dBSPL recovery in the mean hearing level at the 2000Hz, 4000Hz and 8000Hz. In the speech recognition threshold test, marked recovery is defined as any recovery of the maximum speech recognition score (%) by speech recognition threshold test using 67S or 57S Japanese monosirable word tabele (Japan Audiological Society 1967, 1957).
Key secondary outcomes	The secondary outcome are evaluated at 3 month and 6 month after the EAS operation, using pure tone audiometry. In this test, marked effective is defined as less than 40 dBSPL deterioration in the mean hearing level at the 125Hz, 250Hz and 500Hz.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	The EAS choclea implantation is performed under general anesthesia. Same as standard cochlea implant surgeries, an antromastoidectomy is performed, followed by an atticotomy and posterior tympanotomy and insert cochlear implant electrode to cochlea and fix implanted electrode and signal receiver from speach processor. A EAS cochlea implant electrode is inserted into the cochlea, using a round window aproach (Adunka et al.,2004; Skarzynski et al.,2007). This electrode insertion technique is able to preserve residual hearing in low frequencies.
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	18 months-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Adult bilateral profound sensorineural hearing loss patient with a ski-slope type hearing loss corresponding to the frequencies listed here: 1) 125Hz, 250Hz, and 500Hz are under 65dB. 2) 2000Hz is over 80dB. 3) 4000Hz and 8000Hz are over 85dB. One of the above mentioned frequencies may be out of the mentioned decibel lebels by 10dB still be considered as a subject. The maximum speech recognition score in quiet of EAS subject should be under 60% at 65dB in the best aided condition wearing the hearing aid.
Key exclusion criteria	The exclusion criteria are as follows: (1)Acute progressive hearing loss (2)autoimmune disease (3)Hearing loss casused by meningitis, otosclerosis and ossification (4)Malformations or obstruction of the cochlea (5)Conductive hearing loss (6)External ear cojtra indications to using amplification devices
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shin-ichi Usami
Organization	Shinshu University School of Medicine
Division name	Department of Otorhinolaryngology
Zip code
Address	3-1-1 Asahi, Matsumoto, Nagano, JAPAN
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Shin-ichi Usami
Organization	Shinshu University School of Medicine
Division name	Department of Otorhinolaryngology
Zip code
Address	3-1-1 Asahi, Matsumoto, Nagano, JAPAN
TEL
Homepage URL
Email

Sponsor
Institute	Shinshu University Hospital
Institute
Department

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

Other related organizations
Co-sponsor	MED-EL Electro-Medizinische Gerate GMBH
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2011 Year 06 Month 30 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	Completed
Date of protocol fixation	2010 Year 08 Month 26 Day
Date of IRB	2010 Year 09 Month 07 Day
Anticipated trial start date	2011 Year 03 Month 01 Day
Last follow-up date	2015 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	2011 Year 06 Month 30 Day
Last modified on	2022 Year 12 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006245