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Single-sided Deafness and Cochlear Implants

Primary Purpose

Sensorineural Hearing Loss (Disorder)

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
cochlear implant
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sensorineural Hearing Loss (Disorder) focused on measuring hearing loss, cochlear implant, PET, EEG, MEG

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University Hospital Zurich, Division of Otorhinolaryngology ORL

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cochlear Implant

Arm Description

Surgical Implantation of a Cochlear Implant

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 11, 2012
Last Updated
September 3, 2020
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT01749592
Brief Title
Single-sided Deafness and Cochlear Implants
Official Title
Hemispheric Dominance in Single-sided Postlingual Deafness and Changes / Plasticity Induced by Cochlear Implants
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
February 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensorineural Hearing Loss (Disorder)
Keywords
hearing loss, cochlear implant, PET, EEG, MEG

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cochlear Implant
Arm Type
Experimental
Arm Description
Surgical Implantation of a Cochlear Implant
Intervention Type
Device
Intervention Name(s)
cochlear implant
Intervention Description
Surgical implantation of a cochlear implant device
Primary Outcome Measure Information:
Title
Audiometry
Description
Pure tone audiometry Speech audiometry Sound localization in both quiet and noise
Time Frame
up to12 months after invention
Secondary Outcome Measure Information:
Title
PET scan
Description
[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
Time Frame
9 months after intervention
Other Pre-specified Outcome Measures:
Title
EEG
Description
Resting state EEG and EEG with acoustic paradigm.
Time Frame
3, 6 and 12 months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tobias Kleinjung, MD
Organizational Affiliation
University Hospital Zurich, Division of Otorhinolaryngology ORL
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich, Division of Otorhinolaryngology ORL
City
Zurich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31880806
Citation
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.
Results Reference
derived

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Single-sided Deafness and Cochlear Implants

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