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Single-sided Deafness and Cochlear Implants

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01749592
First received: December 11, 2012
Last updated: December 12, 2012
Last verified: December 2012
  Purpose
  • 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 Intervention
Sensorineural Hearing Loss (Disorder)
Device: cochlear implant

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hemispheric Dominance in Single-sided Postlingual Deafness and Changes / Plasticity Induced by Cochlear Implants

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Audiometry [ Time Frame: up to12 months after invention ] [ Designated as safety issue: No ]
    Pure tone audiometry Speech audiometry Sound localization in both quiet and noise


Secondary Outcome Measures:
  • PET scan [ Time Frame: 9 months after intervention ] [ Designated as safety issue: Yes ]
    [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 [ Time Frame: 3, 6 and 12 months after intervention ] [ Designated as safety issue: No ]
    Resting state EEG and EEG with acoustic paradigm.


Estimated Enrollment: 20
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cochlear Implant
Surgical Implantation of a Cochlear Implant
Device: cochlear implant
Surgical implantation of a cochlear implant 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01749592

Contacts
Contact: Nicole M Peter nicole-martina.peter@usz.ch
Contact: Tobias Kleinjung, MD tobias.kleinjung@usz.ch

Locations
Switzerland
University Hospital Zurich, Division of Otorhinolaryngology ORL Recruiting
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Tobias Kleinjung, MD University Hospital Zurich, Division of Otorhinolaryngology ORL
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01749592     History of Changes
Other Study ID Numbers: 2012-0034
Study First Received: December 11, 2012
Last Updated: December 12, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by University of Zurich:
hearing loss
cochlear implant
PET
EEG
MEG

Additional relevant MeSH terms:
Deafness
Hearing Loss
Hearing Loss, Sensorineural
Ear Diseases
Hearing Disorders
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014