Single-sided Deafness and Cochlear Implants

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 Status

Device

Estimated Enrollment

20

Start Date

December 2012

Completion Date

February 8, 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

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

September 2020