Single-sided Deafness and Cochlear Implants

NCT01749592 | Completed DMC

• 1 other identifier: 2012-0034
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Sensorineural Hearing Loss (Disorder)

Keywords

hearing loss; cochlear implant; PET; EEG; MEG

Outcome Measures

Primary Outcomes (1)

• Audiometry

  Pure tone audiometry Speech audiometry Sound localization in both quiet and noise

  up to12 months after invention

Secondary Outcomes (1)

• PET scan

  9 months after intervention

Other Outcomes (1)

• EEG

  3, 6 and 12 months after intervention

Study Arms (1)

Cochlear Implant

EXPERIMENTAL

Surgical Implantation of a Cochlear Implant

Device: cochlear implant

Interventions

cochlear implant DEVICE

Surgical implantation of a cochlear implant device

Cochlear Implant

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-70 years old.
• 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).

You may not qualify if:

• 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.
• Pregnancy (a pregnancy test will be performed in women in the reproductive age group before study enrolment and before postoperative PET scan) and lactation.

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Division of Otorhinolaryngology ORL

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 38253897 DERIVED

• 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.

  PMID: 31880806 DERIVED

MeSH Terms

Conditions

Hearing Loss, Sensorineural; Hearing Loss

Interventions

Cochlear Implants

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neural Prostheses; Implantable Neurostimulators; Electrodes, Implanted; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Prostheses and Implants; Hearing Aids; Sensory Aids

Study Officials

• Tobias Kleinjung, MD

  University Hospital Zurich, Division of Otorhinolaryngology ORL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2012
• First Posted: December 13, 2012
• Study Start: December 1, 2012
• Primary Completion: January 1, 2018
• Study Completion: February 8, 2018
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)