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Single-sided Deafness and Cochlear Implants

NCT01749592 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-09-09

No results posted yet for this study

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

Conditions

  • Sensorineural Hearing Loss (Disorder)

Interventions

DEVICE

cochlear implant

Surgical implantation of a cochlear implant device

Sponsors & Collaborators

  • University of Zurich

    lead OTHER

Principal Investigators

  • Tobias Kleinjung, MD · University Hospital Zurich, Division of Otorhinolaryngology ORL

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2018-01-31
Completion
2018-02-08

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01749592 on ClinicalTrials.gov