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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002778
Receipt No. R000003379
Scientific Title Electric and acoustic stimulation (EAS) type cochlea implantation surgery
Date of disclosure of the study information 2009/11/18
Last modified on 2010/11/22

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Basic information
Public title Electric and acoustic stimulation (EAS) type cochlea implantation surgery
Acronym EAS type cochlea implantation
Scientific Title Electric and acoustic stimulation (EAS) type cochlea implantation surgery
Scientific Title:Acronym EAS type cochlea implantation
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 Maneuver
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
20 years-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 24

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 虎の門病院(東京都)、神戸市立医療センター中央市民病院(兵庫県)、岡山大学附属病院(岡山県)、長崎大学附属病院(長崎県)、宮崎大学附属病院(宮崎県)

Other administrative information
Date of disclosure of the study information
2009 Year 11 Month 18 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 Open public recruiting
Date of protocol fixation
2009 Year 10 Month 16 Day
Date of IRB
Anticipated trial start date
2010 Year 04 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 11 Month 18 Day
Last modified on
2010 Year 11 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003379

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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