Single-sided Deafness and Cochlear Implants

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

• 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

Study Overview

• Status: Completed
• Conditions: Sensorineural Hearing Loss (Disorder)
• Intervention / Treatment: Device: cochlear implant

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • ZH
    • Zurich, ZH, Switzerland, 8091
      • University Hospital Zurich, Division of Otorhinolaryngology ORL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Audiometry	Pure tone audiometry Speech audiometry Sound localization in both quiet and noise	up to12 months after invention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PET scan	[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	9 months after intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
EEG	Resting state EEG and EEG with acoustic paradigm.	3, 6 and 12 months after intervention

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Tobias Kleinjung, MD, University Hospital Zurich, Division of Otorhinolaryngology ORL

Publications and helpful links

General Publications

• Peter N, Kleinjung T, Probst R, Hemsley C, Veraguth D, Huber A, Caversaccio M, Kompis M, Mantokoudis G, Senn P, Wimmer W. Cochlear implants in single-sided deafness - clinical results of a Swiss multicentre study. Swiss Med Wkly. 2019 Dec 27;149:w20171. doi: 10.4414/smw.2019.20171. eCollection 2019 Dec 16.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): February 8, 2018

Study Registration Dates

• First Submitted: December 11, 2012
• First Submitted That Met QC Criteria: December 12, 2012
• First Posted (Estimate): December 13, 2012

Study Record Updates

• Last Update Posted (Actual): September 9, 2020
• Last Update Submitted That Met QC Criteria: September 3, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: PET; EEG; MEG; cochlear implant; hearing loss
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Sensorineural
• Other Study ID Numbers: 2012-0034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No