Single-sided Deafness and Cochlear Implants
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ClinicalTrials.gov Identifier: NCT01749592 |
Recruitment Status
:
Active, not recruiting
First Posted
: December 13, 2012
Last Update Posted
: July 6, 2017
|
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- 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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sensorineural Hearing Loss (Disorder) | Device: cochlear implant | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Hemispheric Dominance in Single-sided Postlingual Deafness and Changes / Plasticity Induced by Cochlear Implants |
Study Start Date : | December 2012 |
Estimated Primary Completion Date : | January 2018 |
Estimated Study Completion Date : | December 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Cochlear Implant
Surgical Implantation of a Cochlear Implant
|
Device: cochlear implant
Surgical implantation of a cochlear implant device
|
- Audiometry [ Time Frame: up to12 months after invention ]Pure tone audiometry Speech audiometry Sound localization in both quiet and noise
- PET scan [ Time Frame: 9 months after intervention ][15O] H2O Positron emission tomography (PET) is performed. The comparison of baseline PET scans and stimulated PET scans will demonstrate task related changes in brain activity
- EEG [ Time Frame: 3, 6 and 12 months after intervention ]Resting state EEG and EEG with acoustic paradigm.

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01749592
Switzerland | |
University Hospital Zurich, Division of Otorhinolaryngology ORL | |
Zurich, ZH, Switzerland, 8091 |
Principal Investigator: | Tobias Kleinjung, MD | University Hospital Zurich, Division of Otorhinolaryngology ORL |
Responsible Party: | University of Zurich |
ClinicalTrials.gov Identifier: | NCT01749592 History of Changes |
Other Study ID Numbers: |
2012-0034 |
First Posted: | December 13, 2012 Key Record Dates |
Last Update Posted: | July 6, 2017 |
Last Verified: | July 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by University of Zurich:
hearing loss cochlear implant PET EEG MEG |
Additional relevant MeSH terms:
Hearing Loss Deafness Hearing Loss, Sensorineural Hearing Disorders Ear Diseases |
Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms |