Single-sided Deafness and Cochlear Implants

Not Applicable

Completed

• Conditions: Sensorineural Hearing Loss (Disorder)
• Interventions: Device: cochlear implant

• Registration Number: NCT01749592
• Lead Sponsor: University of Zurich

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-11
• Study First Submitted QC: 2012-12-12
• Study First Posted: 2012-12-13
• Primary Completion: 2018-01
• Study Completion: 2018-02-08
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-03
• Last Update Posted: 2020-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cochlear Implant	cochlear implant	Surgical Implantation of a Cochlear Implant

Primary Outcome Measures

Name	Time	Method
Audiometry	up to12 months after invention	Pure tone audiometry Speech audiometry Sound localization in both quiet and noise

Secondary Outcome Measures

Name	Time	Method
PET scan	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

Trial Locations

Locations (1)

University Hospital Zurich, Division of Otorhinolaryngology ORL; 🇨🇭 Zurich, ZH, Switzerland