Single-sided Deafness and Cochlear Implants

Study Description

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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

Condition or disease	Intervention/treatment	Phase
Sensorineural Hearing Loss (Disorder)	Device: cochlear implant	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	20 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Hemispheric Dominance in Single-sided Postlingual Deafness and Changes / Plasticity Induced by Cochlear Implants
Study Start Date :	December 2012
Estimated Primary Completion Date :	January 2018
Estimated Study Completion Date :	December 2018

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Cochlear Implant; Surgical Implantation of a Cochlear Implant	Device: cochlear implant; Surgical implantation of a cochlear implant device

Outcome Measures

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Primary Outcome Measures :

1. Audiometry [ Time Frame: up to12 months after invention ]
   Pure tone audiometry Speech audiometry Sound localization in both quiet and noise

Secondary Outcome Measures :

1. 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

Other Outcome Measures:

1. EEG [ Time Frame: 3, 6 and 12 months after intervention ]
   Resting state EEG and EEG with acoustic paradigm.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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Locations

Switzerland
University Hospital Zurich, Division of Otorhinolaryngology ORL
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University of Zurich
ClinicalTrials.gov Identifier:	NCT01749592 History of Changes
Other Study ID Numbers:	2012-0034
First Posted:	December 13, 2012
Last Update Posted:	July 6, 2017
Last Verified:	July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by University of Zurich:

hearing loss; cochlear implant; PET; EEG; MEG

Additional relevant MeSH terms:

Hearing Loss; Deafness; Hearing Loss, Sensorineural; Hearing Disorders; Ear Diseases	Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms