Compassionate Use Arm - ABI541 Auditory Brainstem Implant for Neurofibromatosis Type 2 Patients With Deafness
The Nucleus 24 Auditory Brainstem Implant (ABI) is the only FDA approved device for restoration of meaningful hearing in Neurofibromatosis Type 2 (NF2) patients. This device has been discontinued, meaning that there is no commercially approved device currently available. The replacement model, the ABI541 (an unapproved device), is being investigated in ongoing clinical trials. A compassionate use arm of a clinical trial allows patients with NF2 to be implanted with this new ABI.
NCT02589912 — Neurofibromatosis Type 2
Status: No longer available
http://inclinicaltrials.com/neurofibromatosis-type-2/NCT02589912/
Reorganization of Central Auditory System After Single Sided Deafness: a Functional Magnetic Resonance Imaging Study
The objective is to study the relation between the reorganization of the central auditory system, and the psychophysical deficits in binaural hearing in subjects with single sided deafness.
NCT02534298 — Unilateral Hearing Loss
Status: Completed
http://inclinicaltrials.com/unilateral-hearing-loss/NCT02534298/
Cochlear Implantation for Treatment of Single-sided Deafness
This is a research study to determine whether a cochlear implantation (CI) device can improve hearing in people who are deaf in one ear (known as single-sided deafness).
NCT02532972 — Unilateral Partial Deafness
Status: Terminated
http://inclinicaltrials.com/unilateral-partial-deafness/NCT02532972/
Hearing Handicap in Patients With Single Sided Deafness
Single sided deafness (SSD) refers to asymmetrical hearing loss, where there is a significant worsening of hearing in one ear compared to the other. In Cambridge, the investigators see large numbers of patients with SSD caused by vestibular schwannomas, due to their affiliation with the Neuro-Otology Department, with over 100 new SSD patients being referred every year. Only a small number of studies have explored hearing handicap for those with SSD, and music appreciation has not been investigated, to the best of the investigators knowledge, in this patient group. In the limited number of studies conducted on those with single sided deafness, often only one or two outcome measures have been used, or the patient group has been small. The investigators have a large group of patients with a wide range of aetiologies who have completed several questionnaires as part of their treatment in the single sided deafness clinic and the investigators would like to analyse these data. At present there are different devices available on the NHS for the management of SSD and many studies have explored benefits of Bone Anchored Hearing Aids (BAHA). There is an under-representation of studies looking specifically at CROS aid devices which is relevant given the cost differences involved between devices. Study goals and objectives - To find out what factors drive hearing handicap in SSD patients by analysing the results of several different well validated hearing handicap questionnaires - To find out whether or not it is possible to change hearing handicap in this patient group by looking to see if there is an improvement in questionnaire scores post treatment. - The investigators will also look at a sub-group who will be fitted with both traditional wired CROS aids and more up-to-date wireless aids which have been funded through a research grant, in order to assess whether these are more beneficial. - The investigators will use a new questionnaire developed in-house to further explore the impact of single sided deafness on music appreciation.
NCT02525640 — Hearing Loss
Status: Withdrawn
http://inclinicaltrials.com/hearing-loss/NCT02525640/
Cancer and Deafness Associated With the Use of Platinum Derivatives in Children
A limited number of relatively contradictory studies have suggested that the development of serious ototoxicity in children treated with cisplatin or, more rarely, carboplatin could be partly related to genetic risk factors affecting detoxification enzymes and membrane transporters of platinum derivatives. The objective of this study is therefore to identify genetic variants associated with the development of platinum ototoxicity in patients treated with cisplatin or carboplatin (minimum follow-up of 3 years) for one of the following diseases: neuroblastoma, hepatoblastoma, retinoblastoma, malignant germ cell tumour, osteosarcoma, high-risk or recurrent Wilms' tumour, non-parameningealrhabdomyosarcoma. A total of 180 patients, corresponding to 60 cases with grade 3 or 4 ototoxicity and 120 controls with no signs of ototoxicity (separate complete audiograms for each ear) will be included. A saliva sample will be used to obtain DNA for pharmacogenetic studies. The value of this study will be to define a population at high risk of developing ototoxicity in order to adapt treatment, or even develop preventive treatment of ototoxicity based on antioxidant medications
NCT02425397 — Hearing Loss
Status: Completed
http://inclinicaltrials.com/hearing-loss/NCT02425397/
Development and Clinical Application of Two New Genetic Deafness Gene
The purpose of this study is to develop and applicate two new genetic deafness gene diagnostic kit for Waardenburg syndrome and large vestibular aquduct syndrome.
NCT02418936 — Waardenburg Syndrome
Status: Recruiting
http://inclinicaltrials.com/waardenburg-syndrome/NCT02418936/
Cochlear Implantation for Single-Sided Deafness
The purpose of this investigation is to determine the safety and preliminary efficacy of implanting a cochlear implant (CI) in the profoundly deaf ear of an adult with one normal hearing (NH) ear (termed "single-sided deaf" person, or SSD). The potential subjects will have been deafened post-lingually, thus, at one point the now deafened ear did conduct sound from the periphery. The MED-EL CI system will be implanted in ten (10) SSD patients.The long-term goal of this research program is to determine whether the CI, in combination with the NH ear, may provide improved localization ability and better speech understanding in noise, relative to performance before cochlear implantation (i.e., with the NH ear alone). A secondary long-term goal is to determine whether CI stimulation may reduce tinnitus severity, compared to tinnitus experienced prior to cochlear implantation or when the CI is turned off, after implantation.
NCT02259192 — Single-sided Deafness
Status: Active, not recruiting
http://inclinicaltrials.com/single-sided-deafness/NCT02259192/
Cochlear Implantation in Single Sided Deafness and Asymmetrical Hearing Loss: a Cost/Utility Study.
The investigators assume that cochlear implants in this indication are not only effective but also cost-effective. The investigators' experimental protocol relies on real life therapeutic strategy, where a cochlear implant may be proposed once CROS and bone conductions systems have failed. Thus, all subjects enrolled in our study will try CROS and bone conduction devices. If these trials are ineffective, the remaining subjects will be randomized between two arms (cochlear implantation vs 6 months abstention followed by cochlear implantation). A comparative cost-utility analysis between the two arms, of medical consequences measured in terms of quality of life will identify a preference for a strategy. Specific binaural hearing measurements with respect to each treatment option (abstention, CROS, bone conduction device, cochlear implant) will also be collected.
NCT02204618 — Auditory Processing Disorder, Central
Status: Completed
http://inclinicaltrials.com/auditory-processing-disorder-central/NCT02204618/
Cochlear Implantation in Cases of Single-Sided Deafness
The primary goal of this project is to determine whether subjects with Single-Sided Deafness (SSD) experience an improvement in speech perception, localization, and quality of life with a cochlear implant as compared to an unaided listening condition.
NCT02203305 — Asymmetric Hearing Loss
Status: Completed
http://inclinicaltrials.com/asymmetric-hearing-loss/NCT02203305/
Hemispheric Dominance in Single-sided Postlingual Deafness and Changes / Plasticity Induced by Cochlear Implants
- 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
NCT01749592 — Sensorineural Hearing Loss (Disorder)
Status: Completed
http://inclinicaltrials.com/sensorineural-hearing-loss-disorder/NCT01749592/