Brief Title
Single-sided Deafness and Cochlear Implants
Official Title
Hemispheric Dominance in Single-sided Postlingual Deafness and Changes / Plasticity Induced by Cochlear Implants
Brief Summary
- As the left and right hemisphere are specialized for different auditory tasks, the
proposed study aims at demonstrating different consequences of right or left-sided
deafness for the affected individual.
- Furthermore, the question should be answered if auditory deficits and plastic changes
can be partially reversed by cochlear implantation of the deaf ear.
- Multicenter, prospective, open, non-randomized clinical trial with 5 patients with
right-sided and 5 patients with left-sided sensineural deafness.
- Pre-operative: Audiometry, Sound Localization Audiometry, PET, EEG/MEG
- Comparison of pre-operative investigations with 10 healthy subjects (age and gender
matched control group)
- Cochlea implantation
- Follow-up Visits at 3, 6, 9 and 12 month post-operative: Audiometry, Sound Localization
Audiometry, PET, EEG, Questionnaires
- Trial with medical device
Detailed Description
Postlingual single-sided deafness (SSD) is a type of hearing impairment with normal hearing
in one ear and severely impaired hearing in the other ear. The condition induces multiple
changes of neural plasticity in central auditory pathways. One manifestation reflects an
increased common activation of the contralateral and ipsilateral pathways after stimulation
of the normal hearing ear which is correlated with an increased activity between the
contralateral and ipsilateral hemispheres. As the left and right hemisphere are specialized
for different auditory tasks, the proposed study aims at demonstrating different consequences
of right or left-sided deafness for the affected individual. Furthermore, the question should
be answered if auditory deficits and plastic changes can be partially reversed by cochlear
implantation of the deaf ear. It is assumed that some changes induced by SSD can be detected
only by reversal through a cochlear implant.
Study Type
Interventional
Primary Outcome
Audiometry
Secondary Outcome
PET scan
Condition
Sensorineural Hearing Loss (Disorder)
Intervention
cochlear implant
Study Arms / Comparison Groups
Cochlear Implant
Description: Surgical Implantation of a Cochlear Implant
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
20
Start Date
December 2012
Completion Date
December 2018
Primary Completion Date
January 2018
Eligibility Criteria
Inclusion criteria: • Patients with acquired single sided sensorineural deafness due to
cochlear damage.
- Age: 18-70 years old.
- Onset of SSD within 6 months to 10 years before Study inclusion.
- Normal hearing on the contralateral ear (Hearing thresholds 0.125-2 kHz 25 dB HL or
better, 4-8 kHz 35 dB HL or better, 100% speech discrimination at 80 dB SPL).
- Regular middle ear function on the hearing ear.
- Regular structure of the cochlea and the cochlear nerve (as demonstrated by MRI, MRI
scans are included in the basic assessment of SSD and are no study-specific
investigations).
- Fluency in the German language.
- Subject is willing to comply with all study requirements.
- Impairment in daily life as a consequence of SSD (communication problems, annoyance by
tinnitus perception).
- Subject is not participating in another ongoing research study related to the SSD.
- Subject does not have unrealistic expectations, regarding the outcome of the
intervention.
- Subject has had a trial with conventional acoustic measures in SSD (CROSS, BAHA).
Exclusion criteria: • Uncertainty of correct diagnosis of SSD.
- Retrocochlear cause of SSD (Deafness due to lesions of the acoustic nerve or central
auditory pathways).
- Active middle ear infections.
- Ossification of the cochlear that prevents electrode insertion.
- Tympanic membrane perforation.
- Psychiatric comorbidities such as depression or cognitive deficits.
- Severe coexisting illness with a medium survival of less than 5 years.
- Exposure to radiation with a cumulative effective dose of 5 mSV within the last 5
years (including the ongoing year).
- Increased risk profile for general anesthesia due to cardiovascular comorbidity.
- Metallic implants constituting an exclusion criterium for MEG procedures of the brain.
- Pregnancy (a pregnancy test will be performed in women in the reproductive age group
before study enrolment and before postoperative PET scan) and lactation.
Gender
All
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
Tobias Kleinjung, MD, ,
Location Countries
Switzerland
Location Countries
Switzerland
Administrative Informations
NCT ID
NCT01749592
Organization ID
2012-0034
Responsible Party
Sponsor
Study Sponsor
University of Zurich
Study Sponsor
Tobias Kleinjung, MD, Principal Investigator, University Hospital Zurich, Division of Otorhinolaryngology ORL
Verification Date
June 2018