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 : June 21, 2018
- 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)|
|Official Title:||Hemispheric Dominance in Single-sided Postlingual Deafness and Changes / Plasticity Induced by Cochlear Implants|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||December 2018|
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.
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
|University Hospital Zurich, Division of Otorhinolaryngology ORL|
|Zurich, ZH, Switzerland, 8091|
|Principal Investigator:||Tobias Kleinjung, MD||University Hospital Zurich, Division of Otorhinolaryngology ORL|