Single-sided Deafness and Cochlear Implants

Sponsor

University of Zurich (Other)

Overall Status

Completed

CT.gov ID

NCT01749592

Collaborator

(none)

Enrollment

Location

Arm

62.3

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

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 :

Dec 1, 2012

Actual Primary Completion Date :

Jan 1, 2018

Actual Study Completion Date :

Feb 8, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Cochlear Implant

Surgical Implantation of a Cochlear Implant

Device: cochlear implant

Surgical implantation of a cochlear implant device

Outcome Measures

Primary Outcome Measures

Audiometry [up to12 months after invention]
Pure tone audiometry Speech audiometry Sound localization in both quiet and noise

Secondary Outcome Measures

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

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.