Single-sided Deafness and Cochlear Implants - Full Text View

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:

Genetics Home Reference related topics: nonsyndromic deafness Pendred syndrome

MedlinePlus related topics: Hearing Disorders and Deafness

U.S. FDA Resources

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:	March 2016
Estimated Primary Completion Date:	March 2016 (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 15, 2014
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 February 27, 2015