Single-sided Deafness and Cochlear Implants
This study is currently recruiting participants.
Verified December 2012 by University of Zurich
Sponsor:
University of Zurich
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01749592
First received: December 11, 2012
Last updated: December 12, 2012
Last verified: December 2012
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Purpose
- 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 | Intervention |
|---|---|
|
Sensorineural Hearing Loss (Disorder) |
Device: cochlear implant |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Hemispheric Dominance in Single-sided Postlingual Deafness and Changes / Plasticity Induced by Cochlear Implants |
Resource links provided by NLM:
Further study details as provided by University of Zurich:
Primary Outcome Measures:
- Audiometry [ Time Frame: up to12 months after invention ] [ Designated as safety issue: No ]Pure tone audiometry Speech audiometry Sound localization in both quiet and noise
Secondary Outcome Measures:
- PET scan [ Time Frame: 9 months after intervention ] [ Designated as safety issue: Yes ][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
Other Outcome Measures:
- EEG [ Time Frame: 3, 6 and 12 months after intervention ] [ Designated as safety issue: No ]Resting state EEG and EEG with acoustic paradigm.
| Estimated Enrollment: | 20 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cochlear Implant
Surgical Implantation of a Cochlear Implant
|
Device: cochlear implant
Surgical implantation of a cochlear implant 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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01749592
Contacts
| Contact: Nicole M Peter | nicole-martina.peter@usz.ch | |
| Contact: Tobias Kleinjung, MD | tobias.kleinjung@usz.ch |
Locations
| Switzerland | |
| University Hospital Zurich, Division of Otorhinolaryngology ORL | Recruiting |
| Zurich, ZH, Switzerland, 8091 | |
Sponsors and Collaborators
University of Zurich
Investigators
| Principal Investigator: | Tobias Kleinjung, MD | University Hospital Zurich, Division of Otorhinolaryngology ORL |
More Information
No publications provided
| Responsible Party: | University of Zurich |
| ClinicalTrials.gov Identifier: | NCT01749592 History of Changes |
| Other Study ID Numbers: | 2012-0034 |
| Study First Received: | December 11, 2012 |
| Last Updated: | December 12, 2012 |
| Health Authority: | Switzerland: Swissmedic |
Keywords provided by University of Zurich:
|
hearing loss cochlear implant PET EEG MEG |
Additional relevant MeSH terms:
|
Deafness Hearing Loss Hearing Loss, Sensorineural Hearing Disorders Ear Diseases |
Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013