Clinical Trials Directory

Trials / Completed

CompletedNCT01749592

Single-sided Deafness and Cochlear Implants

Hemispheric Dominance in Single-sided Postlingual Deafness and Changes / Plasticity Induced by Cochlear Implants

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
20 (actual)
Sponsor
University of Zurich · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEcochlear implantSurgical implantation of a cochlear implant device

Timeline

Start date
2012-12-01
Primary completion
2018-01-01
Completion
2018-02-08
First posted
2012-12-13
Last updated
2020-09-09

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT01749592. Inclusion in this directory is not an endorsement.