Single-sided Deafness and Cochlear Implants

NCT ID: NCT01749592

Last Updated: 2020-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2018-02-08

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.

Conditions

Sensorineural Hearing Loss (Disorder)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cochlear Implant

Surgical Implantation of a Cochlear Implant

Group Type: EXPERIMENTAL

cochlear implant

Intervention Type: DEVICE

Surgical implantation of a cochlear implant device

Interventions

cochlear implant

Surgical implantation of a cochlear implant device

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tobias Kleinjung, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Division of Otorhinolaryngology ORL

Locations

University Hospital Zurich, Division of Otorhinolaryngology ORL

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

References

Peter N, Treyer V, Probst R, Kleinjung T. Auditory Cortical Plasticity in Patients with Single-Sided Deafness Before and After Cochlear Implantation. J Assoc Res Otolaryngol. 2024 Feb;25(1):79-88. doi: 10.1007/s10162-024-00928-3. Epub 2024 Jan 22.

Reference Type: DERIVED

PMID: 38253897 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31880806 (View on PubMed)

Other Identifiers

2012-0034

Identifier Type: -

Identifier Source: org_study_id